BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT

    MDR report key: 2832868 · Received November 14, 2012

    Report

    Report Number
    2955842-2012-00940
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 17, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF SHAFT IS ROUGH AND SPLINTERING IS CONFIRMED. VISUAL INSPECTION SHOWS VARIOUS WEAR MARKS WITH LIGHT MATERIAL REMOVAL ACROSS THE ENTIRE TUBE LENGTH. TUBE SURFACE IS ROUGH TO THE TOUCH AT THE DISTAL AND PROXIMAL ENDS. EVIDENCE NOT CONCLUSIVE, BUT WEAR PATTERN MAY BE A RESULT OF IMPROPER CLEANING. NO OTHER DAMAGE FOUND. THE CLEANING AND STERILIZATION USER MANUAL SPECIFICALLY STATES: O WHEN SCRUBBING THE TIP OF CAUTERY INSTRUMENTS, TAKE CARE NOT TO DAMAGE THE INSULATION. O DO NOT EXPOSE INSTRUMENTS TO HYDROGEN PEROXIDE (H2O2), BLEACH, OR ALKALINE-BASED CLEANING AGENTS, AS THIS MAY RESULT IN INSTRUMENT DAMAGE. O PROLONGED EXPOSURE TO EITHER ULTRASONIC CLEANING OR CLEANING AGENTS MAY RESULT IN INSTRUMENT DAMAGE.

    Description of Event or Problem · 1

    IT WAS OBSERVED DURING CENTRAL PROCESSING THAT THE LARGE SUTURE CUT NEEDLE DRIVER INSTRUMENT HAD DAMAGE IN THE INSULATION. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LARGE SUTURECUT NEEDLE DRIVERINSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420296-02 M10120426 546

    Patients

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