BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 2871075 · Received December 12, 2012

    Report

    Report Number
    2955842-2012-01275
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 16, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT GRIP CABLE AT THE DISTAL IDLER IS FRAYED. THE FRAYED CABLE SECTIONS ARE IN VARIOUS LENGTHS AND STICK OUT AT THE WRIST. THE IDLER PULLEY RIM AND AXLE EXHIBIT DAMAGE. ENGINEERING EVALUATION ALSO FOUND THAT THE MAIN TUBE INSULATION IS MISSING MATERIAL AND APPEARS TO BE SCRAPPED OFF. ENGINEERING CONCLUDED THAT THE DAMAGE IS LIKELY DUE TO MISUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REPROCESSING OF THE PROGRASP FORCEPS INSTRUMENT IT WAS NOTED THAT THE CABLE WHERE THE INSTRUMENT ARTICULATES WAS BROKEN. THERE WERE NO MISSING OR FALLEN PIECES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120207 254

    Patients

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