BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 3151039 · Received June 6, 2013

    Report

    Report Number
    2955842-2013-02037
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 14, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE PITCH CABLE WAS BROKEN AT THE WRIST. THE CABLE SEGMENT THAT CONTAINED THE CRIMP WAS STILL INSTALLED IN CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ENGINEERING ALSO FOUND ABNORMAL WEAR THROUGHOUT THE ENTIRE MAIN TUBE. THE SURFACE OF THE MAIN TUBE IS ROUGH IN NATURE, DISCOLORED, AND SPLINTERING OFF. MATERIAL LOSS IS EVIDENT. THE EVIDENCE WAS INCONCLUSIVE, BUT THE DAMAGE WAS MOST LIKELY DUE TO IMPROPER CLEANING PROCESS. 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 SI SURGICAL PROCEDURE THE TENACULUM FORCEPS INSTRUMENT WAS NOTED TO HAVE A BROKEN CABLE. 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
    250519 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420207-06 M10110323 350

    Patients

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