BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 2895525 · Received January 3, 2013

    Report

    Report Number
    2955842-2013-00030
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    November 29, 2012
    Report Date
    December 6, 2012
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING OBSERVED THAT ONE CONDUCTOR WIRE IS BROKEN AT THE YAW PULLEY EXIT. THE WIRE IS DETACHED FROM ITS CONNECTION AT THE GRIP. THE INSTRUMENT FAILED ELECTRICAL CONTINUITY TESTING. THE YAW PULLEY SHOWS NO SIGNS OF ARCING. ENGINEERING EVALUATION ALSO FOUND THAT THE YAW PULLEY IS MISSING A .220 X .060 PIECE OPPOSITE THE CONDUCTOR BREAK, ALLOWING THE GRIP TO MOVE WITHIN THE PULLEY AND HAVE A LARGER RANGE OF MOTION IN YAW. ENGINEERING CONCLUDED THAT IT IS INDETERMINABLE HOW THE PIECE OF YAW PULLEY BROKE. NO OTHER 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 S PROSTATECTOMY PROCEDURE, A WIRE ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT BROKE. THERE WERE NO MISSING OR FALLEN PIECES 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
    2589 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10110301 102

    Patients

    Seq Age Sex Outcome Treatment
    1 DA VINCI S SURG SYSTEM, ACCESSORIES AND ESU.