BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK DISSECTING FORCEPS INSTRUMENT

    MDR report key: 2871121 · Received December 12, 2012

    Report

    Report Number
    2955842-2012-01283
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K061260
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING FOUND ELECTRICAL CONTINUITY, WHICH IS AN INDICATOR OF CAUTERY FUNCTION, PASSES. A FUNCTIONAL CAUTERY TEST WAS PERFORMED USING A GENERATOR AND PK CORD. STEAM WAS GENERATED FROM A WET TOWEL HELD BETWEEN GRIPS WHEN CAUTERY PEDAL WAS PRESSED, INDICATING SUCCESSFUL CAUTERY FUNCTION. ADDITIONALLY, TUBE DAMAGE WAS OBSERVED, HOWEVER NOT REPORTED BY THE SITE. DISTAL END OF MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SCRATCHES ARE .100 - .200 IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS. EVIDENCE IS NOT CONCLUSIVE, BUT DAMAGE MAY HAVE BEEN CAUSED BY MISHANDLING/MISUSE. THE CLEANING AND STERILIZATION USER MANUAL SPECIFICALLY STATES: WHEN SCRUBBING THE TIP OF CAUTERY INSTRUMENTS, TAKE CARE NOT TO DAMAGE THE INSULATION. DO NOT EXPOSE INSTRUMENTS TO HYDROGEN PEROXIDE (H2O2), BLEACH, OR ALKALINE-BASED CLEANING AGENTS, AS THIS MAY RESULT IN INSTRUMENT DAMAGE. PROLONGED EXPOSURE TO EITHER ULTRASONIC CLEANING OR CLEANING AGENTS MAY RESULT IN INSTRUMENT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI S PROCEDURE A PK DISSECTING FORCEPS INSTRUMENT BECAME UNRESPONSIVE. NOTHING WAS REPORTED HAVING FALLEN INTO THE PATIENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK DISSECTING FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420227-03 M10120104 976

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR DA VINCI S SYSTEM INSTRUMENTS AND ACCESSORIES