BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3092977 · Received May 3, 2013

    Report

    Report Number
    2955842-2013-01546
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    March 1, 2013
    Report Date
    April 30, 2013
    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. ENGINEERING CONFIRMED THE ALLEGED COMPLAINT. THE INSTRUMENT HAD A PIECE REMOVED FROM THE YAW PULLEY. THE DAMAGED YAW PULLEY ALLOWED THE JAW GRIP TO OVEREXTEND THE MOTION AND THE JAWS NOT CLOSING PROPERLY. ADDITIONAL OBSERVATIONS WERE FOUND THAT WERE NOT INITIALLY REPORTED BY THE CUSTOMER. THE INSTRUMENT'S JAWS WERE BENT, CAUSING SIDE TO SIDE MISALIGNMENT OF THE GRIPS. THERE WAS A 0.03 OFFSET AT THE TIPS. THE BENT GRIP HAD SEPARATION OF THE YAW PULLEY AND PULLEY COVER AT THE GLUE JOINT, INDICATING OVERLOADING AT THE TIP. ENGINEERING EVALUATION CONCLUDED THAT THE DAMAGES WERE LIKELY DUE TO MISHANDLING. ELECTRICAL CONTINUITY TESTING WAS PERFORMED AND PASSED. THE ENDOWRIST INSTRUMENTS INSTRUCTIONS FOR USE (IFU) SPECIFICALLY STATES: GENERAL PRECAUTIONS AND WARNINGS - HANDLE INSTRUMENTS WITH CARE. AVOID MECHANICAL SHOCK OR STRESS THAT CAN CAUSE DAMAGE TO THE INSTRUMENTS. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A REPORTABLE EVENT; HOWEVER, THE REPORTED MALFUNCTION IF TO REOCCUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    DURING A DA VINCI SI HYSTERECTOMY PROCEDURE, THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT REPORTEDLY WOULD NOT CLOSE. NOTHING REPORTEDLY FELL INTO A PATIENT. 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
    194729 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10120126 193

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR DA VINCI SI SYSTEM INSTRUMENTS AND ACCESSORIES