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

Model Number 480422-01

Device Problem Difficult to Remove (1528)

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

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

The vessel sealer extend instrument has been returned and evaluated by the failure analysis (fa) team.Failure analysis investigations did not replicate nor confirm the customer reported complaint.The instrument was placed and driven on an in-house system.The instrument passed the self-test homing.The instrument moved intuitive with full range of motion in all directions.The grips opened and closed properly.The instrument passed the electrical continuity, energy delivery, cut, jaw gap verification and grip force tests.The energy delivery test was performed with various orientations of the grip tips and passed.No ceramic dots missing.No damage was found.A review of the logs shows no errors.No image or procedure video was provided for review.A review of the device logs for the vessel sealer extend instrument (480422-01/l90210510-0269) associated with this event has been performed.Per this review of the logs, the vessel sealer extend was last used on (b)(6) 2022.This complaint is being reported based on the following conclusion: it was reported that the vessel sealer extend instrument grips did not open and/or were clamped and could not be opened.Medical intervention may be required in the event that the vessel sealer extend fails to unclamp from tissue when commanded by the user or system.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.

Event Description

It was reported that during a da vinci-assisted surgical procedure, the vessel sealer extend instrument stopped working.The jaws got stuck and would not open.The customer received a fault and performed troubleshooting.The customer noted that an intuitive surgical inc.(isi) field service engineer (fse) informed them to return the product to analyze the initial problem.The procedure was completed with no reported injury.Intuitive surgical, inc.(isi) performed follow-up to obtain additional information.However, no further details have been received as of the date of this report.

• 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: 14973729
• MDR Text Key: 304285029
• Report Number: 2955842-2022-12880
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 10886874115661
• UDI-Public: (01)10886874115661(10)L90210510
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2022
• 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: L90210510 0269
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Female