BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3863946 · Received June 10, 2014

    Report

    Report Number
    2955842-2014-03543
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 13, 2014
    Report Date
    May 12, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. THE CUSTOMER REPORTED COMPLAINT WAS CONFIRMED BY FAILURE ANALYSIS. THE INSTRUMENT PITCH CABLE WAS BROKEN AT THE PROXIMAL CLEVIS HUB. IN ADDITION THE INSTRUMENT GRIP CABLE WAS ALSO FRAYED AT THE DISTAL CLEVIS HUB. THE PROXIMAL AND DISTAL CLEVIS DOES NOT EXHIBIT ANY WEAR. FRAYED STRANDS STUCK OUT AT THE WRIST. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS THE INSTRUMENT MAIN TUBE HAD SCRATCH MARKS/ABRASIONS. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS WITH LIGHT MATERIAL REMOVAL. SCRATCHES WERE NOT ALIGNED WITH THE TUBE AXIS. NO OTHER DAMAGE FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER FRAYED WIRES AND MAIN TUBE SCRATCH WERE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PRIOR TO STARTING A DA VINCI PROCEDURE, THE PROGRASP FORCEPS INSTRUMENT HAD A BROKEN WIRE. THERE WERE NO MISSING OR FALLEN PIECES REPORTED. THERE WAS NO ALLEGATION OF ANY HARM, INJURY, OR ADVERSE OUTCOME TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340878 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-10 M10131119 002

    Patients

    Seq Age Sex Outcome Treatment
    1