BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3870043 · Received June 12, 2014

    Report

    Report Number
    2955842-2014-03594
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 15, 2014
    Report Date
    May 15, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND ONE GRIP CLOSE CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. SMALL FRAYED STRANDS STUCK OUT AT THE WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. ADDITIONALLY, THE PITCH DOWN CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. FRAYED STRANDS ALSO STUCK OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST ARE NOT DAMAGED. AN ADDITIONAL FINDING WAS VARIOUS SCRATCHES ON THE DISTAL END OF THE MAIN TUBE EXHIBITING LIGHT MATERIAL REMOVAL. THE SCRATCHES WERE .168 - .146 IN LENGTH AND NOT AXIALLY ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI SURGICAL PROCEDURE, A BROKEN CABLE WAS IDENTIFIED ON THE PROGRASP FORCEPS INSTRUMENT. THE INSTRUMENT WAS NOT USED ON THE PATIENT. NOTHING REPORTEDLY FELL INTO A PATIENT AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348566 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-11 M10140215 320

    Patients

    Seq Age Sex Outcome Treatment
    1