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

Model Number 480422-01

Device Problem Failure to Deliver Energy (1211)

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

Event Date 02/16/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted total benign hysterectomy surgical procedure, the vessel sealer extend (vse) would not seal at all.The surgeon adjusted every aspect of her attempting to seal and changed how much/where she was trying to seal, but it still would not seal at all.Sealing worked initially, but then stopped.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) followed up with the initial reporter and obtained the following additional information: the customer had successfully used the vse prior to the issue occurring.The surgeon then attempted to seal on uterus tissue, but there was no tissue effect.The customer would receive a system error stating the following; "system check error, about sufficient amount of tissue." there was no tone displayed by the system indicating that seal was in progress, nor did the system give the seal complete tones.The customer attempted to re-grab tissue, but that did not resolve the issue.The customer removed the faulty vse and used a new vse successfully.There was no medical intervention required.The procedure was completed with no report of patient injury.

Manufacturer Narrative

The vessel sealer extend (vse) instrument has been returned and evaluated by the failure analysis (fa) team.Failure analysis investigations replicated and confirmed the customer reported complaint.Failure analysis found the primary finding of continuity test failure be related to the customer reported complaint.The instrument failed on multiple attempts during a continuity test.The instrument energy cable was installed onto an e-100 system and was recognized, however, when the energy delivery pedal was pressed on the system there was an error message.The error message read: "ensure appropriate amount of tissue in jaws.Incomplete seal cycle." the tower used for testing was folded multiple times to attempt to seal again, yet no change was observed.A grip force test was performed and passed.A cut test was performed and passed.The housing was removed from the back end, no obvious damage was found to the conductor wires on the back end or the distal end.Review of the logs found no failures related to the reported complaint.The root cause for the continuity test failure is not determinable/applicable.Advanced failure analysis performed additional investigations and confirmed above the initial fa findings.The instrument failed continuity from the wrist at the upper electrode (jaw w/ ceramic dots).Intermittent failed continuity is most likely due to the conductor wire separating from the weld inside the jaw.This failure can be attributed to component manufacturing.Error messages reported by the customer can also be attributed to the same failure; the error is triggered and activation interrupted when continuity is lost.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.No image or procedure video was provided for review.A review of the instrument log for the vessel sealer extend (vse) instrument (480422-01/m912109280028) associated with this event has been performed.Per the logs, the instrument was last used on (b)(6) 2022.This complaint is being reported based on the following conclusion: the vessel sealer extend instrument had a broken conductor wire at the weld.The damaged/broken conductor wire has potential for electrical discharge at a location other than intended.While there was no harm or injury to the patient, the reported failure mode could likely cause or contribute to an adverse event if it were to recur.

• 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: 14191551
• MDR Text Key: 289962647
• Report Number: 2955842-2022-11247
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)M91210928
• 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: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• 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: M91210928 0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: ISIFA2022-01-C
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES