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

Model Number 480422-01

Device Problem Entrapment of Device (1212)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

Based on the current information provided, the root cause of the customer reported failure mode cannot be determined as the instrument was discarded by the site and is not available for evaluation.If additional information is received, a follow-up mdr will be submitted.The logs were reviewed by an intuitive surgical, inc.(isi) advanced failure analysis engineer (fae) and the following findings were obtained: there are no errors recorded during the use of this vse.No image or video clip for the reported event was submitted for review.This complaint is being reported due to the following conclusion: it was reported that during a da vinci-assisted colostomy closure procedure, fat tissue kept sticking to the jaws of the vessel sealer extend (vse) instrument which the surgeon would wiggle off.The surgeon confirmed that no tissue was cut to release the instrument and he did not perform any repairs to the tissue.At this time, it is unknown what caused the device entrapment issue to occur.

Event Description

It was reported that during a da vinci-assisted colostomy closure procedure, the vessel sealer extend (vse) was sticking to tissue.The same vse was used to complete the procedure robotically.Intuitive surgical, inc.(isi) followed up with the surgeon and obtained the following information: during the colostomy closure procedure (1st procedure on (b)(6) 2022), the fatty tissue was sticking to the jaws of the vse and the surgeon removed the tissue by wiggling the tissue off.The surgeon did not have to cut tissue to release the instrument, nor do any tissue repairs.There was no bleeding or insufficient sealing seen.The same instrument was used to complete the procedure.The bedside assist cleaned the jaws properly each time they removed the vse instrument.There were no post-operative complications seen.Isi followed up with the clinical sales representative (csr) and obtained the following information: the vse have been discarded.

• 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: 14054360
• MDR Text Key: 298520809
• Report Number: 2955842-2022-10944
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L90220130
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480422-01
• Device Catalogue Number: 480422
• Device Lot Number: L90220130 0078
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2022
• 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