BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2972501 · Received February 21, 2013

    Report

    Report Number
    2955842-2013-00580
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 31, 2013
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT ENGINEERING EVALUATION FOUND THAT THE GRIP CABLE WAS FRAYED AT THE DISTAL IDLER PULLEY. THE FRAYED STRANDS STUCK OUT AT THE WRIST. THE OTHER CABLES AT WRIST WERE NOT DAMAGED. THE INSTRUMENT PASSED ELECTRICAL CONTINUITY TESTING. ENGINEERING FOUND THAT THE FRAYED GRIP CABLE WAS DERAILED AT THE DISTAL IDLER PULLEY. THE GRIPS COULD STILL OPEN AND CLOSE, BUT MOVEMENT WAS NOT PRECISE. ENGINEERING CONCLUDED THE CABLE DERAILMENT WAS LIKELY DUE TO THE CABLE LOSING CONTACT WITH THE PULLEY DURING WRIST ARTICULATION. THE FLEET ANGLE BETWEEN PROXIMAL AND DISTAL PULLEYS MAY HAVE CONTRIBUTED TO THE DERAILMENT. IN ADDITION, ENGINEERING FOUND THE ONE GRIP WAS BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF GRIPS. THERE WAS A .024 OFFSET AT THE TIPS INDICATING OVERLOADING AT THE TIP. 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 PROSTATECTOMY PROCEDURE THAT THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS NOTED TO HAVE FRAYED WIRES AT THE DISTAL END. NO MISSING OR FALLEN PIECES WERE REPORTED. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75958 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10111007 712

    Patients

    Seq Age Sex Outcome Treatment
    1 DAVINCI SI SYSTEM, ESU, INSTRUMENTS & ACCESSORIES