BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3832755 · Received May 27, 2014

    Report

    Report Number
    2955842-2014-03225
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS INVESTIGATION FOUND THE INSTRUMENT'S PITCH CABLE WAS FRAYED. THE CONDUCTOR WIRES WERE INTACT AND UNDAMAGED, BUT THE DRIVE CABLE WAS FRAYED. THE PITCH UP CABLE WAS FRAYED AT THE DISTAL CLEVIS HUB. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT THE WRIST WERE NOT DAMAGED. 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 IN CENTRAL PROCESSING, IT WAS NOTED THAT A FRAYED WIRE WAS OBSERVED ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310490 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 N10131123 038

    Patients

    Seq Age Sex Outcome Treatment
    1