BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOWEL GRASPER INSTRUMENT

    MDR report key: 3441318 · Received October 31, 2013

    Report

    Report Number
    2955842-2013-04843
    Event Type
    Malfunction
    Date Received
    October 31, 2013
    Date of Event
    October 3, 2013
    Report Date
    October 7, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS FOUND THAT THE GRIP CABLES WERE BROKEN AT THE WRIST. THE INSTRUMENT WAS NON-INTUITIVE AS A RESULT. FAILURE ANALYSIS ALSO OBSERVED THAT THE MAIN TUBE INSULATION WAS SCRATCHED AND SOME OF THE INSULATION HAD BEEN REMOVED. THE SCRATCHES MEASURED APPROXIMATELY .023 - .114 IN LENGTH. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI SI TOTAL BENIGN HYSTERECTOMY PROCEDURE THE BOWEL GRASPER INSTRUMENT CABLE BROKE AT THE DISTAL END OF THE INSTRUMENT. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560853 BOWEL GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420177-04 S10121231 656

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR DA VINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES