BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP FORCEPS INSTRUMENT

    MDR report key: 3163596 · Received June 11, 2013

    Report

    Report Number
    2955842-2013-02109
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 20, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING EVALUATION FOUND THAT THE PITCH CABLE WAS LOOSE. THE INTUITIVE MOTION WAS NOT FUNCTIONING DUE TO A LOOSE PITCH CABLE FOUND AT THE WRIST. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. THE CABLE CRIMP REMAINED IN THE CLEVIS. THE LOOSE PITCH CABLE WAS OBSERVED TO BE FRAYED AS WELL. THE FRAYED SEGMENTS WERE VARIOUS IN LENGTHS. THE HOUSING WAS REMOVED AND THE PITCH CABLES WERE FOUND LOOSE AT CLAMPING PULLEY, BUT NO LOOSE CLAMPING PULLEY SCREW WAS FOUND. 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 A DA VINCI SI HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY PROCEDURE THE PROGRASP FORCEPS INSTRUMENT REPORTEDLY DID NOT WORK AT ALL. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264041 PROGRASP FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10130225 989

    Patients

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