BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC GRASPER INSTRUMENT

    MDR report key: 2930227 · Received January 25, 2013

    Report

    Report Number
    2955842-2013-00297
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    GEI
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE COMPLAINT OF THE TORN INSULATION WAS CONFIRMED. THE BLACK TUBE INSULATION WAS DAMAGED AT THE DISTAL END. THE INSULATION WAS GOUGED ON ONE SIDE AND HAD A .060 X .045 PIECE MISSING ROUGHLY 1.8 ABOVE THE SNAKE WRIST. THE INSULATION ALSO HAD VARIOUS SCRATCH MARKS WITH NO MATERIAL MISSING BELOW THE DAMAGED SECTION. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS A BENT TUBE. THE TUBE WAS SLIGHTLY BENT ROUGHLY 6 ABOVE THE SNAKE WRIST. THE DISTAL END ROLL MOTION WAS NOT ALIGNED WITH PROXIMAL END OF TUBE DUE TO BENDING. EVIDENCE IS NOT CONCLUSIVE, HOWEVER, THE DAMAGE IS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. DO NOT USE AN INSTRUMENT TO CLEAN DEBRIS FROM ANOTHER INSTRUMENT INTRAOPERATIVELY. THIS MAY RESULT IN DAMAGE TO THE INSTRUMENTS OR OTHER UNINTENDED CONSEQUENCES, SUCH AS DISCONNECTION OF THE INSTRUMENT TIP. 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 OBSERVED DURING CENTRAL PROCESSING THAT THE INSULATION OF THE THORACIC GRASPER INSTRUMENT WAS TORN. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35227 THORACIC GRASPER INSTRUMENT ENDOSCOPIC INSTRUMENT GEI INTUITIVE SURGICAL,INC. 420343-01 S10120510 295

    Patients

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