BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 15482087 · Received September 25, 2022

    Report

    Report Number
    2955842-2022-14227
    Event Type
    Malfunction
    Date Received
    September 25, 2022
    Date of Event
    August 24, 2022
    Report Date
    August 26, 2022
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    10886874115661
    PMA / PMN Number
    K173337
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. THE INSTRUMENT HAS BEEN RETURNED AND EVALUATED BY THE FAILURE ANALYSIS (FA) TEAM ON 10/06/2022. THE INSTRUMENT WAS PLACED ON AN IN-HOUSE SYSTEM AND PASSED THE ENGAGEMENT TEST BUT FAILED THE INTUITIVE MOTION TEST WHEN THE MASTER TOOL MANIPULATOR'S (MTMS) WERE MANIPULATED. THE HOUSING WAS REMOVED, AND IT WAS FOUND THAT THE WASHER FOR THE GRIP-OPEN KEG WAS DISLODGED. THIS DISLODGEMENT PREVENTS THE KEG FROM MOVING UP AND DOWN PROPERLY WHICH IN TURN PREVENTS THE JAWS FROM OPENING/CLOSING. THIS IS A MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE VESSEL SEALER EXTEND (VSE) INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS INVESTIGATIONS REPLICATED/CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FOR CLARIFICATION, THE WASHER OF THE GRIP RING ADAPTER ASSEMBLY WAS SEEN DISLODGED UPON HOUSING REMOVAL. AS A RESULT THE GRIPS WOULD NOT OPEN AND CLOSE PROPERLY WHEN THE GRIP LEVER WAS ACTUATED. THE INSTRUMENT ALSO DID NOT PASS SELF-TEST WHEN INSTALLED ON THE SYSTEM ARM. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF A DISLODGED WASHER TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. ROOT CAUSE IS ATTRIBUTED TO A COMPONENT FAILURE. A REVIEW OF THE INSTRUMENT LOG FOR THE VESSEL SEALER EXTEND (480422-01/L11220711-0334) ASSOCIATED WITH THIS EVENT HAS BEEN PERFORMED. PER LOGS, THE VESSEL SEALER EXTEND WAS LAST USED ON (B)(6) 2022. NO IMAGE OR PROCEDURE VIDEO WAS PROVIDED FOR REVIEW. THIS COMPLAINT IS BEING REPORTED BASED ON THE FOLLOWING CONCLUSION: FAILURE ANALYSIS CONFIRMED THE ENDOWRIST VESSEL SEALER INSTRUMENT HAS A COMPONENT FAILURE THAT WOULD NOT ALLOW FOR THE GRIPS TO OPEN. THE INSTRUMENT WASHER OF THE GRIP RING ADAPTER ASSEMBLY WAS DISLODGED AND WOULD LEAD TO INTERMITTENT FAILURES. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE ENDOWRIST VESSEL SEALER 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.

    Description of Event or Problem · 0

    REFER TO H10/H11 FOR FOLLOW-UP INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE VESSEL SEALER EXTEND (VSE) INSTRUMENT WAS OBSERVED TO HAVE NOT FULLY OPENED NOR CLOSED DURING DISSECTION OF TISSUE. THERE WAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW-UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337689 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L11220711 0334 10886874115661

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES