MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-25 for DAVINCI XI 380652-38 N/A manufactured by Intuitive Surgical, Inc.
[184983783]
Based on the current information provided, the cause of the patient? S intra-operative complication is unknown. Isi attempted to contact the site to gather additional patient details. However, as of the date this report, no new information has been obtained. If additional information is obtained, a follow-up mdr will be submitted. Isi received the usm involved with this complaint and completed the device evaluation. Failure analysis investigations could not replicate the reported recognition 31009 and 31087 faults. However, the errors were confirmed via error logs/system logs. The unit recognized and functioned with no issues on multiple installed instruments during testing. A review of the system and instrument logs has been performed. Other than the recognition issues reported by the customer (31009 and 31087 faults) which, according to the customer were unrelated to the incident, the logs showed no other issues that would indicate a product issue. Additionally, all instruments used in the case were used in subsequent procedures, with the exception of the following: all instruments used in the case were used in subsequent procedures, with the exception of the following: suction irrigator (part #480299-04; lot #m10180914-0172)? Which is a single use instrument and site reviews have shown that no complaints were filed against the instrument monopolar curved scissors (part #470179-19; lot #n11181031-0020) - the event occurred on the final use of the instrument and site reviews have shown that no complaints were filed against the instrument 2 white stapler 30 reloads (part #48630w-03) which are single use instrument accessories and site reviews have shown that no complaints were filed against the stapler reloads this complaint is being reported due to the following conclusion: during a da vinci-assisted surgical procedure, the patient experienced uncontrolled bleeding. The patient subsequently expired. Although a nurse who was present during the procedure indicated that the uncontrolled bleeding had nothing to do with the robot and the robotics coordinator explained that that bleeding and patient death were unrelated to the da vinci surgical system, the cause of the intra-operative complication is unknown.
Patient Sequence No: 1, Text Type: N, H10
[184983784]
It was initially reported that during a da vinci-assisted pulmonary lobectomy procedure, the patient experienced uncontrolled bleeding and subsequently expired from the intra-operative complication. In addition, it was reported that the surgical staff had encountered an instrument recognition issue with arm #4 during the procedure. However, the initial reporter (a robotics coordinator) indicated that the uncontrolled bleeding was not caused by the performance of the da vinci surgical system or the recognition issue that occurred. Due to the instrument recognition issue, the surgical staff contacted an intuitive surgical, inc. (isi) technical support engineer (tse) for assistance. The tse reviewed the site's system logs and identified a number of (b)(4) faults. Both faults types are consistent with the recognition issue observed by the customer. The arm or universal surgical manipulator (usm) was replaced by an isi field service engineer (fse) on (b)(6) 2019. On 22-aug-2019, isi contacted the robotics coordinator and the following additional information regarding the reported event was obtained: the robotics coordinator was not in the room when the reported intra-operative complication occurred. However, the robotics coordinator spoke to a nurse who was in the room and questioned her if the robot had anything to do with the intra-operative complication. According to the robotics coordinator, the nurse stated that the uncontrolled bleeding "had absolutely nothing to do with the robot. " the robotics coordinator explained that that bleeding was related to a number of patient factors such as size and sickness. The robotics coordinator even mentioned that she was hesitant to even mention the patient's death since it was unrelated to the da vinci surgical system. The robotics coordinator also indicated that she had informed an isi fse, that the patient's death was unrelated to the robot or issues with arm #4. In addition, on 22-aug-2019, isi received the following additional information regarding the reported event from an isi clinical sales representative (csr): the csr was present during the majority of the case. He confirmed that the surgical staff encountered instrument recognition issues with arm #4. He reportedly left to support another case before the reported intra-operative complication and subsequent patient death occurred. However, the csr explained that his manager had spoken to a nurse at the site the following day and was informed that the uncontrolled bleeding and patient death were unrelated to the robot.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2020-10229 |
| MDR Report Key | 9881060 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-25 |
| Date of Report | 2019-08-21 |
| Date of Event | 2019-08-20 |
| Date Mfgr Received | 2019-08-21 |
| Device Manufacturer Date | 2017-03-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | R |
| 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. Life Threatening; 3. Required No Informationntervention | 2020-03-25 |