BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP (TM) FORCEPS INSTRUMENT

    MDR report key: 2944607 · Received February 5, 2013

    Report

    Report Number
    2955842-2013-00394
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 10, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS RETURNED WITH FRAYED CABLE SECTIONS LOCATED AT VARIOUS LENGTHS, THE FRAYED CABLES WERE STICKING OUT ON THE WRIST. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI SI HYSTERECTOMY PROCEDURE, THE CUSTOMER NOTED A BROKEN WIRE ON THE PROGRASP FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48431 PROGRASP (TM) FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10121109 199

    Patients

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