BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16383684 · Received February 15, 2023

    Report

    Report Number
    2955842-2023-10699
    Event Type
    Malfunction
    Date Received
    February 15, 2023
    Date of Event
    January 23, 2023
    Report Date
    January 23, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874120767
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING FAILURE TO UNCLAMP, AN INVESTIGATION IS IN PROGRESS TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE FORCE BIPOLAR INSTRUMENT FOR EVALUATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE MODE HAS NOT BEEN DETERMINED. A FOLLOW-UP MDR WILL BE SUBMITTED IF THE INSTRUMENT IS RETURNED (POST FAILURE ANALYSIS EVALUATION) OR IF ADDITIONAL INFORMATION IS RECEIVED. A REVIEW OF THE PROVIDED IMAGES WERE PERFORMED BY AN INTUITIVE SURGICAL, INC. (ISI) FAILURE ANALYSIS ENGINEER. IT LOOKS LIKE THE BASE OF THE GRIP THAT IS USUALLY POSITIONED IN THE DISTAL CLEVIS HAS BEEN DISLODGED FROM ITS NORMAL POSITION. THIS WOULD HAVE CAUSED THE DIFFICULTY WITH THE JAWS NOT OPENING. THERE IS NO OTHER DAMAGE OBSERVED TO THE CABLES OR CONDUCTOR WIRE. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT THE JAWS OF THE FORCE BIPOLAR INSTRUMENT WOULD NOT OPEN ON COMMAND BY THE SURGEON. JAW DISLODGMENT COULD RESULT IN THE TIPS BEING STUCK AND UNABLE TO BE OPENED WITH MTM ACTIVATION OR INSTRUMENT RELEASE KIT (IRK) USE. 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 WHILE GRASPING TISSUE. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT THE INSTRUMENT JAWS FAIL TO OPEN FROM TISSUE WHEN COMMANDED BY THE USER OR SYSTEM. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE GRIP/HINGE TO BECOME DISLODGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED BENIGN HYSTERECTOMY SURGICAL PROCEDURE, THE JAWS OF A FORCE BIPOLAR INSTRUMENT WERE NOT OPENING. IT WAS ALSO OBSERVED THAT THE INSTRUMENT¿S PLATE HOLDING THE WIRE IN PLACE HAD COME UNDONE. THE SURGEON IMMEDIATELY STOPPED THE PROCEDURE. THE INSTRUMENT WAS REMOVED WITH THE ENTIRE TROCAR AND A GRASPER WAS USED TO MOVE THE PLATE SO THE INSTRUMENT WOULD FIT THROUGH THE TROCAR. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURIES. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH A NURSE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND NO DAMAGES WERE NOTED. THERE WAS NO SYSTEM GENERATED FAULTS. THE JAWS WERE NOT STUCK ON TISSUE WHEN THIS ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A BACK UP INSTRUMENT OF SAME KIND. THERE WERE NO PATIENT INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656084 ENDOWRIST FORCE BIPOLAR NAY INTUITIVE SURGICAL, INC 471405-06 K12210913 0075 00886874120767

    Patients

    Seq Age Sex Outcome Treatment
    1 Female DA VINCI INSTRUMENTS AND ACCESSORIES.