BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP (TM) FORCEPS

    MDR report key: 2935915 · Received January 30, 2013

    Report

    Report Number
    2955842-2013-00317
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 27, 2012
    Report Date
    January 4, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH A FRAYED PITCH CABLE AT DISTAL CLEVIS HUB. THERE WAS NO DAMAGE FOUND AT THE CLEVIS. THE FRAYED SEGMENT WAS APPROXIMATELY 0.03 IN LENGTH. NO OTHER CABLE 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 S THYROIDECTOMY 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
    41525 PROGRASP (TM) FORCEPS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M10120727 348

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI S SYSTEM INSTRUMENTS AND ACCESSORIES