BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP (TM) FORCEPS

    MDR report key: 2870244 · Received December 12, 2012

    Report

    Report Number
    2955842-2012-01254
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 24, 2012
    Report Date
    November 15, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE PITCH CABLE WAS FOUND TO BE BROKEN AT THE DISTAL CLEVIS HUB. THE CABLE SEGMENT THAT CONTAINS THE CRIMPS WAS MISSING IN THE CLEVIS. THE CLEVIS DID NOT EXHIBIT ANY DAMAGE OR WEAR MARKS. ADDITIONAL OBSERVATION NOT REPORTED BY SITE WAS MAIN INSULATION TUBE DAMAGE. THE DISTAL END OF MAIN TUBE HAD VARIOUS SCRATCH MARKS AND DAMAGE NEAR THE DISTAL END. ENGINEERING CONCLUDED THAT DAMAGE WAS LIKELY DUE TO MISHANDLING. 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. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DAVINCI SI HYSTERECTOMY PROCEDURE, THE CUSTOMER NOTED THAT THE 'PROGRASP FORCEPS INSTRUMENT WOULD NOT CLOSE(NOTHING FELL INTO THE PATIENT, NO PATIENT HARM).'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRASP (TM) FORCEPS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120906 379

    Patients

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