BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADIERE FORCEPS INSTRUMENT

    MDR report key: 3882405 · Received June 18, 2014

    Report

    Report Number
    2955842-2014-03769
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 22, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE ONE GRIP CABLE FRAYED AT THE DISTAL IDLER PULLEY. FRAYED STRANDS STUCK OUT AT THE INSTRUMENT'S WRIST. OTHER CABLES AT THE WRIST WERE NOT DAMAGED. THE CONDUCTOR WIRES WERE INTACT AND NOT DAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE FRAYED CABLE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, A BROKEN WIRE WAS NOTED ON THE CADIERE FORCEPS INSTRUMENT. NOTHING REPORTEDLY FELL INTO A PATIENT AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356872 CADIERE FORCEPS INSTRUMENT ENDOSCOPIC INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420049-08 M10131122 435

    Patients

    Seq Age Sex Outcome Treatment
    1