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

Model Number 480422-01

Device Problems Failure to Deliver Energy (1211); Device Dislodged or Dislocated (2923)

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

Event Date 02/22/2022

Event Type  malfunction  

Event Description

It was reported that during a da vinci-assisted low anterior resection surgical procedure, the vessel sealer extend would not activate and the blade would not retract.The procedure was completed with no patient harm.The patient-related information was not available.

Manufacturer Narrative

Intuitive surgical, inc.(isi) received the instrument involved with this complaint and completed the device evaluation.Failure analysis (fa) investigations replicated and confirmed the reported complaint.The instrument did not pass self-test during the initialization process.Review of error logs confirmed several homing failures (error 22026) during initialization on system sk4287 on (b)(6) 2022, indicating the instrument would not work.No dislodged blade was observed at the garage track upon visual inspection.However, self-check never passed when installed on a da vinci in-house system after many attempts.An additional observation not reported by the site was that the washer of the grip ring adapter assembly was seen dislodged.As a result, the grips would not open and close properly when the grip lever was actuated.Failure analysis found this failure to be related to the customer reported complaint.Root cause of this issue is attributed to a component failure.Further analysis was conducted by failure analysis engineer on 25-mar-2022.Confirming that the grip tube retaining ring was dislodged and was not recovered inside the housing.The dislodged retaining ring resulted in the non-intuitive motion of the instrument jaws and homing failures.Additionally, the grip tube washer was found slightly dislodged from its intended location.The instrument failed homing after logged use time, suggesting the grip tube retaining ring dislodged mid-procedure.There was no indication of a potential sealing issue found in the logs or given by the customer.This failure is attributed to workmanship issue.A review of the site's complaint history does not show any additional complaints related to this product and/or this event.A review of the instrument logs for the vessel sealer extend (part# 445010 / sn: (b)(4)/ sequence # 0167) associated with this event was performed.The instrument was last used on (b)(6) 2022 on system serial# (b)(4) with 0 use remaining.Based on this review, the instrument was not used in subsequent procedure(s) after the alleged event reported in this record.There was no image or video clip submitted for review.This complaint is considered a reportable malfunction due to the following conclusion: based on failure analysis, the vessel sealer instrument had a dislodged retaining ring which could impact sealing effectiveness.Deficiencies in sealing may lead to inadequate hemostasis.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: 14139331
• MDR Text Key: 289512451
• Report Number: 2955842-2022-11136
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L92211215
• 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: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• 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: L92211215 0167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2021
• Is the Device Single Use?: No
• 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