BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3864426 · Received June 10, 2014

    Report

    Report Number
    2955842-2014-03565
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 30, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 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 FRAYED CABLE IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI LOW ANTERIOR RESECTION SURGICAL PROCEDURE, DURING IRRIGATION, BY CONFIRMING THE TIP OF THE INSTRUMENT, IT WAS FOUND THAT THE WIRE ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT HAD CAME OFF FROM THE PULLEY AND THE WIRE WAS BROKEN. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED. 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
    341277 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10140320 554

    Patients

    Seq Age Sex Outcome Treatment
    1