BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 8321257 · Received February 8, 2019

    Report

    Report Number
    2955842-2019-10094
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 14, 2019
    Report Date
    January 14, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K173337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE INSTRUMENT INVOLVED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS (FA) INVESTIGATION DID NOT CONFIRM THE REPORTED COMPLAINT OF NOT CAUTERIZING. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST AND NO PHYSICAL DAMAGE WAS OBSERVED AT THE GRIP ASSEMBLY. THE CABLE CORD OF THE INSTRUMENT WAS CONNECTED TO A GENERATOR WITHOUT EXCESSIVE FORCE. AN ENERGY ACTIVATION TEST WAS CONDUCTED ON THE SYSTEM, AND FA NOTED NO ERROR OR FAULTS WERE OBSERVED DURING THE IN-HOUSE TESTING. A WET PAPER TOWEL WAS HELD BETWEEN THE INSTRUMENT GRIPS AND SMOKE WAS OBSERVED WHEN THE SEAL PEDAL WAS PRESSED. THE STEAM GENERATED FROM THE TOWEL INDICATED ACTIVE POWER AND COMPLETE CIRCUIT. NO LOSS OF POWER AND NO INTERMITTENT ENERGY WERE OBSERVED. A GRIP FORCE TEST WAS PERFORMED, AND NOTED A MEASUREMENT OF 6.02LFB IN STRAIGHT ORIENTATION, 6.68 LBF IN YAW, AND 6.53 LBF FOR PITCH. ALL READINGS WERE ABOVE THE MINIMUM REQUIREMENT OF 4.25 LBF. AN ELECTRODE GAP TEST WAS CONDUCTED AND THE INSTRUMENT PASSED. THE GAPS BETWEEN THE GRIPS MEASURED 0.002¿, WHICH IS IN RANGE OF 0.001¿ AND 0.007¿. THE LOGS FOR THE INSTRUMENT COULD NOT BE OBTAINED. BASED ON THE INFORMATION PROVIDED, THIS EVENT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, IT WAS ALLEGED THAT THE ENDOWRIST VESSEL SEALER EXTEND INSTRUMENT WOULD NOT CAUTERIZE. WHILE THERE WAS NO REPORT OF ANY PATIENT HARM, ADVERSE OUTCOME OR INJURY, RECURRENCE OF THE REPORTED FAILURE MODE COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED GASTRIC PACING SURGICAL PROCEDURE, THE CUSTOMER OBSERVED THE ENDOWRIST VESSEL SEALER EXTEND WAS NOT CAUTERIZING. THE PROCEDURE WAS COMPLETED WITH NO REPORTED 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
    114180 ENDOWRIST VESSEL SEALER EXTEND NAY INTUITIVE SURGICAL, INC 480422-01 L10170020

    Patients

    Seq Age Sex Outcome Treatment
    1