BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP (TM) FORCEPS INSTRUMENT

    MDR report key: 2972698 · Received February 21, 2013

    Report

    Report Number
    2955842-2013-00590
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 22, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT INSTRUMENT WAS FOUND BROKEN AT THE PROXIMAL CLEVIS TO THE MAIN TUBE INTERFACE. THE CLEVIS WAS FOUND TO BE DISLODGED FROM THE MAIN TUBE AS A RESULT. NO MISSING PIECE WAS OBSERVED. ENGINEERING CONCLUDED THAT THE BREAKAGE WAS LIKELY DUE TO OVERLOADING AT THE TIP. NO OTHER DAMAGE 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 BENT AT THE TIP. ACCORDING TO THE INFORMATION PROVIDED BY THE CUSTOMER, THE PROGRASP FORCEPS INSTRUMENT WAS NOT USED ON THE PATIENT AND IT WAS NEVER INSERTED IN THE SYSTEM. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76306 PROGRASP (TM) FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M11121109 331

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR DAVINCI SI SYSTEM, INSTRUMENTS AND ACCESSORIES