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

Model Number 480422-01

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 03/14/2023

Event Type  malfunction  

Event Description

Intuitive surgical, inc.(isi) received vessel sealer extend (vse) instrument as an rma.There was no alleged malfunction reported against this product.

Manufacturer Narrative

Although there is no claim against the product, an investigation was completed to determine the cause of the rma.The vessel sealer extend (vse) instrument was analyzed and found to have no failure.The instrument was placed and operated on an in-house system.It successfully passed the self-test and homing procedures.The instrument exhibited intuitive movement with a full range of motion in all directions.The grips functioned properly, and the grip force test yielded a result of 8.024 lbs.No ceramic dots were found to be missing.Upon reviewing the logs, no errors were found.An additional observation, not previously reported by the site, is that the instrument failed the electrical continuity test.There is no apparent damage to the conductor wires.Furthermore, the instrument failed the energy delivery test while on the in-house system.The instrument was transferred to engineering for further investigation regarding the failed electrical continuity issue.Initial failure analysis confirmed that the instrument failed the continuity test for one of the jaws.X-ray analysis revealed a break in the conductor wire at the weld for that jaw.There was no complaint against the product to assess the effect of its failure.Advanced technical review (results): a review of the logs for the vessel sealer extend associated with this event has been performed by an intuitive surgical, inc.(isi) afa.The following additional information was provided: dsp logs showed that the instrument was installed 2x and passed homing 2x.Qty 9 cut complete and qty 2 seal events were recorded with no errors.Msc logs show no relevant errors.E100 logs show qty 2 coag events with no errors and qty 20 seal events, of which qty 11 had high initial starting impedance errors.

• 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: 17945414
• MDR Text Key: 326013519
• Report Number: 2955842-2023-19241
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L89230405
• 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
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• 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: L89230405 0247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Date Manufacturer Received: 09/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2023
• 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