MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for DA VINCI 380614-13 N/A manufactured by Intuitive Surgical, Inc.
[184980860]
Based on the current information provided, the cause of the patient? S intra-operative complication and subsequent death is unknown. There is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred during the surgical procedure. If additional information is received, a follow-up mdr will be submitted. 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 are in line with normal system functionality. The log review supports the customer claim that there was no product issue during the case. Additionally, all instruments used in the case were used in subsequent procedures. The da vinci si system user manual states the following: caution: ensure all installed instruments are visible in the surgeon console view before proceeding to prevent inadvertent harm to the patient. Warning: for patient safety, the surgeon must not match grips nor move instruments whose tips are not visible in the stereo viewer. Failure to observe this warning can cause serious harm to the patient. This complaint is being reported due to the following conclusion: during a da vinci-assisted inguinal hernia repair procedure, the patient experienced bleeding and as a result, the case was converted to open surgery. The patient subsequently expired in the icu. Although the surgical staff indicated that there was no direct influence of the da vinci surgical system on the vessel, the cause of the intra-operative complication is unknown. Blank mdr fields: follow-up was attempted, but the patient information was either unknown or unavailable. The expiration date is not applicable. Implant date is blank because the product is not implantable. The initial reporter section that are not available for the site are blank. This report has been generated in response to fda inspectional observations dated 06-mar-2020.
Patient Sequence No: 1, Text Type: N, H10
[184980861]
It was initially reported that during a da vinci-assisted inguinal hernia repair procedure, the patient experienced aortic bleeding and the case was converted to open surgery. The patient reportedly expired in the intensive care unit (icu). On 16-nov-2018 and 19-nov-2018, intuitive surgical, inc. (isi) obtained the following additional information regarding the reported event from the isi clinical sales representative (csr): the surgical procedure was not recorded on video. An assistant in the operating room (or) reportedly inserted a camera incorrectly and therefore, visualization was not optimal. The camera was inserted incorrectly from the start of the surgical procedure. The site attributed the incorrect insertion of the camera to user-error. While reportedly looking for the instruments, the surgeon assumed she was pressing on the aorta. The event occurred while the surgeon was in the process of placing mesh and her head was in the high resolution stereo view (hrsv). The surgical staff indicated that there was no direct influence of the da vinci surgical system on the vessel injury. After the bleeding was observed, the case was converted to open surgery. The patient sustained an estimated blood loss of greater than 3000 ml. During the event, the patient was administered additional anesthesia to? Support reanimation.? The surgical procedure was completed via open surgery. The patient expired in the icu on the evening of (b)(6) 2018. On 26-nov-2018, isi obtained the following additional information reported the reported event: at the time the event occurred, a monopolar curved scissors (mcs) instrument was installed on arm #1 and an unspecified grasper instrument installed on arm #2. In addition, when the event occurred, the surgeon did not have direct view of the instruments? Tips. The surgeon/site attributed the intra-operative complication and death to possible user-error. As a result of the intra-operative complication, the patient underwent? Open vascular surgery? With? Aortic bi-iliac prosthesis implantation.? The patient required blood transfusions. According to the surgeon or site, the cause of the patient? S death was? Heart failure due to prolonged shock (major blood loss).? On (b)(6) 2020, isi contacted the surgeon and obtained the following additional information regarding the patient: the patient had previously unknown vascular disease with significant aortic plaques. The patient also had a history of diabetes. In relation to the reported event, the patient suffered hemorrhagic shock due to an iatrogenic perforation of the aorta. As a result, the following was administered: 10 units of blood replacement, 6 fresh frozen plasma (ffp), 4x2g heamocomplettan, and 1g cyclocarpa. Furthermore, the surgeon noted? Therefore vascular aortic replacement and afterwards intensive care treatment.? Th patient expired the same day of the surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2955842-2020-10231 |
| MDR Report Key | 9881218 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2018-11-15 |
| Date of Event | 2018-11-06 |
| Date Mfgr Received | 2018-11-15 |
| Device Manufacturer Date | 2015-04-30 |
| 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 | DA VINCI |
| Generic Name | PATIENT SIDE CART |
| Product Code | NAY |
| Date Received | 2020-03-25 |
| Model Number | 380614-13 |
| 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 |