BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TENACULUM FORCEPS INSTRUMENT

    MDR report key: 2851892 · Received November 29, 2012

    Report

    Report Number
    2955842-2012-01130
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    GEI
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF A WIRE STICKING OUT IS CONFIRMED. THREE OF FOUR GRIP CABLES ARE BROKEN AT THE DISTAL IDLERS. IDLER PULLEYS SPIN FREELY AND DO NOT EXHIBIT DAMAGE. CABLE SEGMENTS STICK OUT AT WRIST. UNUSUAL FOR MORE THAN ONE CABLE TO BREAK. ADDITIONAL OBSERVATIONS NOT REPORTED BY SITE ARE TUBE DAMAGE AND CORRODED CLAMPING PULLEYS. MAIN TUBE EXHIBITS WEARING WITH LIGHT MATERIAL REMOVAL AND A ROUGH SURFACE FINISH THROUGHOUT THE ENTIRE TUBE LENGTH. HOUSING WAS REMOVED TO FIND ALL CLAMPING PULLEYS AND THE ROLL BUSHING (EACH MADE FROM ALUMINUM) EXHIBITING A WHITE DISCOLORATION AND SEVERE PITTING CORROSION. EVIDENCE NOT CONCLUSIVE, BUT INSTRUMENT WAS LIKELY EXPOSED TO HARSH CHEMICALS DURING CLEANING PROCESS. NO OTHER DAMAGE FOUND. 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 PRIOR TO STARTING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF REPORTED THAT THE TIPS OF THE TENACULUM FORCEPS INSTRUMENT WOULD NOT CLOSE AND WIRES WERE STICKING OUT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENACULUM FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT GEI INTUITIVE SURGICAL,INC. 420207-06 M10110331 257

    Patients

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