BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROGRASP (TM) FORCEPS

    MDR report key: 2890328 · Received December 29, 2012

    Report

    Report Number
    2955842-2012-01480
    Event Type
    Malfunction
    Date Received
    December 29, 2012
    Report Date
    November 29, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. ENGINEERING OBSERVED THAT THE INSTRUMENT WAS FOUND WITH PITCH CABLE FRAYED AND LOOSE AT THE DISTAL CLEVIS HUB. THE CLAMPING PULLEY SCREWS WERE NOT LOOSE. NO DAMAGE WAS FOUND AT THE CLEVIS. THE INSTRUMENT HAS 1 USE REMAINING. 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 A FRAYED CABLE WAS NOTICED ON THE PROGRASP FORCEPS INSTRUMENT DURING CENTRAL PROCESSING. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROGRASP (TM) FORCEPS ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420093-08 M11120510 952

    Patients

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