BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 2902382 · Received January 8, 2013

    Report

    Report Number
    2955842-2013-00092
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    November 26, 2012
    Report Date
    December 11, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS RETURNED WITH A FRAYED GRIP CABLE. THE GRIP CABLE IS FRAYED AT THE DISTAL IDLER PULLEY AND ALSO BY THE PROXIMAL CLEVIS. THE FRAYED STRANDS STICK OUT AT THE WRIST. ENGINEERING EVALUATION ALSO FOUND THAT THE DISTAL END OF THE MAIN TUBE HAS VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. THE SCRATCHES ARE SHORT IN LENGTH AND NOT ALIGNED WITH THE TUBE AXIS, SUGGESTING THAT THE DAMAGE TO THE TUBE WAS CAUSED BY INSTRUMENT COLLISIONS OR ROUGH HANDLING. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPROCESSING OF THE PROGRASP FORCEPS INSTRUMENT, IT WAS OBSERVED THAT THE WIRE AT THE TIP OF THE INSTRUMENT WAS BROKEN. THERE WERE NO MISSING OR FALLEN PIECES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9294 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120910 611

    Patients

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