MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC DAVINCI XI PATIENT SIDE CART, 4-ARM

Model Number 380652-36

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)

Event Date 11/04/2021

Event Type  Death  

Manufacturer Narrative

Based on the current information provided, the root cause of the injury and patient expiring is unknown. There was no report or allegation from the customer of a deficiency of the da vinci system, instrumentation or accessories associated with the reported incident. Therefore, there are no products expected for return to intuitive surgical, inc. (isi) for failure analysis evaluation. A follow up mdr will be submitted if additional information is received. A review of the site's complaint history does not show any additional complaints related to this product and/or this event. Verification of the event details via system logs and log reviews cannot be performed at this time because the event date of the procedure is unknown. No image or video clip for the reported event was submitted for review. A medical review was performed by an isi medical safety officer and the following information was provided. Based upon the description in the description of event, there is insufficient information to make a determination if the da vinci system, instrumentation, and/or accessories caused or contributed to the iliac artery injury resulting in a hemorrhage and death. It is unknown what instruments were being used at the time of injury. It is unknown as to what instrument directly injured the iliac artery. The degree of the injury to the iliac artery is unknown. It is unknown what surgical task the surgeon was performing at the time of the injury. The surgeon¿s level of experience is unknown. It is unknown if the surgeon is qualified to perform an arterial repair. Based on the information provided, this event is being reported due to the following conclusion: during a da vinci-assisted malignant hysterectomy procedure, there was an injury to the iliac artery which resulted in bleeding. The surgeon elected to convert the case to open; however, the patient subsequently expired. Although there is no allegation that a malfunction of a da vinci system, instrument, or accessory occurred, the cause of the intra-operative complication is unknown.

Event Description

It was reported that during a da vinci-assisted malignant hysterectomy procedure, an injury to the iliac artery occurred and there was a hemorrhage. The surgeon initially tried to control the bleeding robotically but ended up converting the procedure to open. The patient expired. Intuitive surgical, inc. (isi) made multiple follow-up attempts to contact the surgeon, robotic coordinator, risk management, surgical service director, and executive director of surgical services to obtain additional information. However, no further details have been received as of the date of this report.

• Brand Name: DAVINCI XI
• Type of Device: PATIENT SIDE CART, 4-ARM
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 12995439
• MDR Text Key: 282179671
• Report Number: 2955842-2021-11739
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 380652-36
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A

Patient Treatment Data

Date Received: 12/14/2021 Patient Sequence Number: 1

Treatment

DA VINCI INSTRUMENTS AND ACCESSORIES