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 11/07/2023

Event Type  Injury  

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) instrument and perforated the bowel.The surgeon was reportedly using a tip-up fenestrated grasper instrument in one hand and a vse instrument 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 instrument, 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) clinical sales representative (csr) has since discussed the event with the surgeon.Since the event, the surgeon has since switched to using two fenestrated tip-up grasper instruments for running the bowel; and in the last six cases, there have been no issues.

Manufacturer Narrative

The vse instrument has not been returned to isi for failure analysis evaluation.Therefore, the cause of the operative complication cannot be determined.The logs show the vse instrument was installed on the system six times and passed homing six times.There were 61 cut events which were completed without any errors.The logs show there were 64 seal events and 18 coag events completed without error.The logs show no errors related to this instrument.

• 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: 18270633
• MDR Text Key: 329757635
• Report Number: 2955842-2023-20570
• 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 0362
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 12/05/2023
• 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.
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White