BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2842859 · Received November 21, 2012

    Report

    Report Number
    2955842-2012-01039
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 25, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF INSTRUMENT WIRES ARE BROKEN WAS CONFIRMED. INSTRUMENT WAS FOUND WITH FRAYED PITCH CABLE AT DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. FRAYED SEGMENT IS APPROXIMATELY 0.03 IN LENGTH. NO OTHER CABLE DAMAGE WAS FOUND. 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.

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. COMPLAINT OF INSTRUMENT WIRES ARE BROKEN WAS CONFIRMED. INSTRUMENT WAS FOUND WITH FRAYED PITCH CABLE AT DISTAL CLEVIS HUB. NO DAMAGE WAS FOUND AT THE CLEVIS. FRAYED SEGMENT IS APPROXIMATELY 0.03 IN LENGTH. NO OTHER CABLE DAMAGE WAS FOUND. 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 DURING A DA VINCI SI SURGICAL PROCEDURE, THE SURGICAL STAFF REPORTED SEEING BROKEN WIRES ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M11120313 127

    Patients

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