BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENESTRATED BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3970930 · Received July 31, 2014

    Report

    Report Number
    2955842-2014-04638
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    April 30, 2014
    Report Date
    July 2, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THAT THE PITCH CABLE WAS FRAYED AND LOOSE AT THE DISTAL IDLER. THE INSTRUMENT HOUSING WAS REMOVED AND THE CABLE WAS FOUND TO BE BROKEN AT THE CLAMPING PULLEY ON THE PROXIMAL END. NO OTHER DAMAGE WAS FOUND. FAILURE ANALYSIS INVESTIGATION ALSO FOUND THE FOLLOWING ADDITIONAL DAMAGES TO THE INSTRUMENT: THERE WERE CHAR MARKS ON THE GRIP BASE AND ON THE SIDE OF THE YAW PULLEY. THERE WERE NO BROKEN PIECES AND NO MATERIAL MISSING. VISUAL INSPECTION OF THE CONDUCTOR WIRE FOUND PART OF THE BLACK INSULATION LIFTED UP, BUT STILL ATTACHED, AT THE YAW PULLEY AREA. IT WAS CONCLUDED THAT THE INSULATION DAMAGE WAS LIKELY DUE TO MISHANDLING/MISUSE. 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 MDR REPORTABLE EVENT; HOWEVER, THE FRAYED CABLE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT, IF THE MALFUNCTION WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI HYSTERECTOMY PROCEDURE, A BROKEN CABLE WAS IDENTIFIED ON THE FENESTRATED BIPOLAR FORCEPS INSTRUMENT. THE INSTRUMENT WAS NOT MOVING PROPERLY. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO THE 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
    448015 FENESTRATED BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420205-05 M10130528 348

    Patients

    Seq Age Sex Outcome Treatment
    1