BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5MM MONOPOLAR CAUTERY INSTRUMENT

    MDR report key: 2884087 · Received December 21, 2012

    Report

    Report Number
    2955842-2012-00820
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF CAN SEE METAL BEYOND THE INSULATION IS CONFIRMED. BLACK TUBE INSULATION IS DAMAGED AT THE DISTAL END. INSULATION IS GOUGED ON ONE SIDE AND HAS A .100 X .040 PIECE MISSING ROUGHLY .240 ABOVE THE SNAKE WRIST. INSULATION EXHIBITS VARIOUS OTHER SCRATCHES/GOUGES AT THE DISTAL END WITHOUT MATERIAL REMOVAL. ADDITIONAL OBSERVATION NOT REPORTED BY SITE IS A BENT MAIN TUBE. MAIN TUBE IS BENT ROUGHLY 4 BELOW THE DISTAL TIP. BEND ANGLE IS ROUGHLY 5 DEGREES, BUT BEND BECOMES MORE APPARENT WHEN TUBE IS ROTATED ALONG ROLL AXIS. EVIDENCE NOT CONCLUSIVE, BUT BENDING DAMAGE IS LIKELY DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE 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. 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.

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING CENTRAL PROCESSING THAT THE 5MM MONOPOLAR CAUTERY INSTRUMENT HAD A HOLE IN THE INSULATION. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MM MONOPOLAR CAUTERY INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420142-04 S10120501 147

    Patients

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