BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3790010 · Received May 5, 2014

    Report

    Report Number
    2955842-2014-02759
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S PITCH CABLE TO BE FRAYED. THE CONDUCTOR WIRES WERE INTACT AND UNDAMAGED, HOWEVER THE DRIVE CABLE WAS FRAYED. THE PITCH UP CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. FRAYED STRANDS WERE OBSERVED TO BE STICKING OUT AT THE WRIST OF THE INSTRUMENT. THE OTHER CABLES AT THE WRIST OF THE INSTRUMENT WERE UNDAMAGED. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER, THE REPORTED FRAYED CABLE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN CENTRAL PROCESSING, FRAYED CABLES WERE IDENTIFIED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268426 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 N10131123 577

    Patients

    Seq Age Sex Outcome Treatment
    1