BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC ELECTROSURGICAL INSTRUMENT

    MDR report key: 8477874 · Received April 3, 2019

    Report

    Report Number
    2955842-2019-10245
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    February 8, 2019
    Report Date
    March 14, 2019
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    PMA / PMN Number
    K112263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTUITIVE SURGICAL, INC. (ISI) HAS NOT RECEIVED THE TIP COVER ACCESSORY OF THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT INVOLVED WITH THIS COMPLAINT FOR FAILURE ANALYSIS INVESTIGATION. THEREFORE, THE ROOT CAUSE OF THE CUSTOMER REPORTED FAILURE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION IS RECEIVED AND/OR IF THE ACCESSORY IS RETURNED A FOLLOW-UP MDR WILL BE SUBMITTED TO THE FDA. ISI DID RECEIVE THE MCS INSTRUMENT ASSOCIATED WITH THIS COMPLAINT AND COMPLETED THE DEVICE EVALUATION. FAILURE ANALYSIS DID NOT REPLICATE NOR CONFIRM THE CUSTOMER REPORTED COMPLAINT OF ARCING. THERE WAS NO SIGN OF ARCING ON THE INSTRUMENT. THE INSTRUMENT WAS PLACED AND DRIVEN ON AN IN-HOUSE SYSTEM AND FOUND TO BE FULLY FUNCTIONAL. THE INSTRUMENT PASSED THE RECOGNITION AND ENGAGEMENT TESTS. THE INSTRUMENT MOVED INTUITIVELY WITH FULL RANGE OF MOTION IN ALL DIRECTIONS. THE TIPS OPENED AND CLOSED PROPERLY. ENERGY WAS DELIVERED WITHOUT ANY ISSUES AND THE ELECTRICAL CONTINUITY TEST PASSED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: IT WAS ALLEGED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MCS INSTRUMENT ARCED. ALTHOUGH THERE WAS NO PATIENT HARM OR INJURY, IF THIS MALFUNCTION WERE TO RECUR IT COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT. AT THIS TIME, IT IS UNKNOWN WHAT CAUSED THE ARCING TO OCCUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE MONOPOLAR CURVED SCISSORS (MCS) INSTRUMENT HAD A ¿SHORT¿ AND MAY HAVE EXHIBITED "ARCING". THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER TO GATHER ADDITIONAL INFORMATION FOR THIS EVENT; HOWEVER, THE REPORTER HAD NO FURTHER INFORMATION ON THE INSTRUMENT ISSUE OTHER THAN WHAT WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272881 ENDOSCOPIC ELECTROSURGICAL INSTRUMENT TIP COVER ACCESSORY NAY INTUITIVE SURGICAL, INC 400180-14 NA

    Patients

    Seq Age Sex Outcome Treatment
    1