MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for DAVINCI XI 380652-38 N/A manufactured by Intuitive Surgical, Inc.
[184981066]
Based on the current information provided, the cause of the patient? S intra-operative complication and subsequent death are unknown. Isi has attempted to contact the site to gather additional information regarding the patient and reported event. However, as of the date of this report, no new information has been obtained. If additional information is received, a follow-up mdr will be submitted. Isi has received the tip-up fenestrated grasper instrument (part # 470347-11; lot # n10181221-0064) associated with this complaint and completed investigations. The instrument was found to have a broken pitch cable at the distal clevis hub. The broken cable segment that contains the crimp was still installed in the clevis. The instrument was found to have the main tube broken but still attached at the proximal clevis. No material was found missing as the main tube broke inside the clevis. This failure is most commonly caused by mishandling/ misuse. The instrument was also found to have various scratch marks with light material removed on the main tube. The scratch marks were 0. 334? - 0. 047 in length and were not aligned with the tube axis. This failure is most commonly caused by mishandling/misuse. A review of the system and instrument logs has been performed. There were no observed events in the system logs that would suggest a product issue, and logged events are in line with normal system functionality. The log review supports the customer claim that there was no system issue during the case. Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: permanent cautery spatula (part # 470184-13; lot # n10190417-0071)? Was returned to isi with a customer reported complaint that the instrument was missing an input disc. Failure analysis could not confirm the customer reported issue. There was no material missing or damage found. Curved bipolar dissector (part # 470347-11; lot # n10181221-0065) and site reviews have shown that no complaints were filed against the instrument. Stapler 45 instrument (part # 470298-12; lot # t10181126-0062) and site reviews have shown that no complaints were filed against the instrument. Curved-tip stapler 45 (part # 470535-05; lot # t10190325-0012) and site reviews have shown that no complaints were filed against the instrument. Curved-tip stapler 30 (part # 470530-08; lot # t10190603-0027) and site reviews have shown that no complaints were filed against the instrument. This complaint is being reported due to the following conclusion: during a da vinci-assisted pulmonary lobectomy procedure, the patient? S pulmonary artery ruptured and as a result, the case was converted to open surgery. Although the robotics coordinator spoke to various surgical staff members about the event and indicated that there is no belief or allegation that the da vinci surgical system contributed to the rupture of the pulmonary artery and subsequent patient death, the cause of the intra-operative complication is unknown. Follow-up was attempted, but the patient information was either unknown or unavailable. The expiration date is not applicable. The product is not implantable. This report has been generated in response to fda inspectional observations dated march 06-mar-2020.
Patient Sequence No: 1, Text Type: N, H10
[184981067]
It was initially reported that during a da vinci-assisted pulmonary lobectomy procedure, the patient's pulmonary artery allegedly ruptured. As a result, the case was converted to open surgery. However, the patient expired on the table. There was no allegation that a malfunction of a da vinci system, instrument, or accessory occurred and caused/ contributed to the intra-operative complication and subsequent patient death. On (b)(4) 2019, intuitive surgical, inc. (isi) contacted the isi clinical sales associate (csa), and the following additional information regarding the reported event was obtained: the csa was present during the surgical procedure. He did not know if the surgical procedure was recorded on video. Prior to when the intra-operative complication had occurred, the surgical staff encountered an issue where a tip-up fenestrated grasper instrument got "jammed" or stuck. The surgical staff was unable to remove the instrument with troubleshooting. An unspecified time later, the pulmonary artery reportedly? Ruptured.? As a result, the patient side cart (psc) was undocked from the patient and the case was converted to open surgery. The csa left the operating room at that time. The csa was informed later that the patient expired on the table. There is no allegation at this time that a da vinci product caused or contributed to the intra-operative complication or the patient's subsequent death. On (b)(4) 2019, isi contacted the isi clinical sales representative (csr) who was also present during the surgical procedure. She confirmed that during the case, a tip-up fenestrated grasper instrument had gotten stuck. The surgical staff was able to remove the tip-up fenestrated grasper instrument by removing the robotic arm that the instrument was installed on. Later during the case, bleeding was observed from the pulmonary artery or a branch from the artery. As a result, the surgeon made the decision to convert the surgical procedure to open surgery. The csr indicated that the tip-up fenestrated grasper instrument that had gotten stuck was used by the surgeon for retraction and was not used in the area where the bleeding was observed. After the case was converted to open surgery, the csr left the operating room. She had not spoken to the surgical staff regarding the reported event. There were no allegations that a da vinci device caused or contributed to the intra-operative bleed and subsequent patient death. On (b)(4) 2019, isi contacted the robotics coordinator and the following additional information regarding the reported event was obtained: the robotics coordinator was not present during the case. However, she spoke to various members of the surgical staff who were present during the procedure. According to the robotics coordinator, the issue regarding the tip-up fenestrated grasper instrument was unrelated to the patient's intra-operative complication and subsequent death. She confirmed that there was no tissue stuck in between the instrument's jaws when the alleged issue occurred. The surgical staff removed the instrument by removing the arm that the instrument was installed on. Based on her conversations with the surgical staff, there was no belief or allegation that the da vinci surgical system caused or contributed to the patient's intra-operative complication and subsequent death. She could not confirm what type of vessel complication had occurred. She also did not know what surgical task the surgeon was performing when the intra-operative complication occurred. The site is still investigating the incident. She will call me back if there is any allegation that the da vinci surgical system caused or contributed to the patient's intra-operative complication and/or death. The robotics coordinator mentioned however that she had not spoken to the surgeon directly regarding the case. Prior to ending the call, the robotics coordinator reiterated that the surgical staff does not believe that the da vinci surgical system caused or contributed to the patient's intra-operative complication and/or death.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2019-11016 |
| MDR Report Key | 9881471 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-25 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-09-04 |
| Date Mfgr Received | 2019-09-04 |
| Device Manufacturer Date | 2017-05-18 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID WANG |
| Manufacturer Street | 3410 CENTRAL EXPRESSWAY |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4085232100 |
| Manufacturer G1 | INTUITIVE SURGICAL, INC |
| Manufacturer Street | 3410 CENTRAL EXPRESSWAY |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAVINCI XI |
| Generic Name | PATIENT SIDE CART, 4-ARM |
| Product Code | NAY |
| Date Received | 2020-03-25 |
| Model Number | 380652-38 |
| Catalog Number | N/A |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTUITIVE SURGICAL, INC |
| Manufacturer Address | 3410 CENTRAL EXPRESSWAY SANTA CLARA CA 95051 US 95051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Required No Informationntervention | 2020-03-25 |