MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST; VESSEL SEALER EXTEND

Model Number 480422

Device Problem Insufficient Information (3190)

Patient Problem Bowel Perforation (2668)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

A return material authorization (rma) was not issued for return as the customer reported that the instrument was disposed; therefore, a failure analysis evaluation cannot be performed.The log review showed that the vessel sealer extend (vse) instrument was installed on the system eight times and passed homing eight times.The instrument was used for approximately 80 minutes.There were 90 cut events that were completed without any errors.The logs show there were 44 seal events for this instrument, that were completed without error.The e-100 logs show there were 92 seal events, of which 91 were completed without error.There was 1 seal event that had a high initial starting impedance error ((b)(4)).Multiple seal events were completed successfully after the failure.There were 18 coag events that were completed without error.There were no vse related errors in the logs.

Event Description

It was reported that during a da vinci-assisted gastric bypass (roux-en-y) surgical procedure, the surgeon grasped the bowel using a vessel seal extend (vse) and perforated the bowel.The surgeon stated using a tip-up fenestrated grasper in one hand and a vse in the other hand, to examine and to count the small bowel (run the bowel).Feeding the small bowel hand over hand, the surgeon counts in centimeters (cm) to assure there is enough length after creating the pouch for the stomach.When the surgeon went to grasp the small bowel with the vse, a hole was created.The bowel perforation was sutured closed.The procedure was completed robotically.There were no post operative complications.The intuitive surgical, inc.(isi) sales representative has since discussed with the surgeon, prior to running the bowel, about switching from a vse instrument to using another fenestrated tip-up grasper instrument.The surgeon has since switched to using two fenestrated tip-up grasper instruments for running the bowel; and in the last six cases, there's been no issues.

• Brand Name: ENDOWRIST
• Type of Device: VESSEL SEALER EXTEND
• 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: 18246033
• MDR Text Key: 329480314
• Report Number: 2955842-2023-20571
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422
• Device Catalogue Number: 480422
• Device Lot Number: K18230629 0304
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES