BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARYLAND BIPOLAR FORCEPS INSTRUMENT

    MDR report key: 3905454 · Received July 1, 2014

    Report

    Report Number
    2955842-2014-04003
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 18, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K050369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. FAILURE ANALYSIS FOUND THE INSTRUMENT'S BIPOLAR YAW PULLEY TO BE BROKEN. VISUAL INSPECTION FOUND THE YAW PULLEY TO BE BROKEN AT THE DISTAL END EXPOSING THE CONDUCTOR WIRE. THE INSTRUMENT FAILED THE ELECTRICAL CONTINUITY TEST. THE CONDUCTOR CABLE DID NOT TOUCH THE GRIPS. THE AREA THAT BROKE OFF WAS RETURNED WITH THE INSTRUMENT AND FITS WHERE THE BREAK IS LOCATED. THERE WAS NO MATERIAL MISSING. THE BROKEN PIECE MEASURED APPROXIMATELY 0.255 X 0.095. FAILURE ANALYSIS CONCLUDED THAT THE BROKEN BIPOLAR YAW PULLEY MAY BE DUE TO MISHANDLING/MISUSE. NO OTHER DAMAGE WAS FOUND. THE INSTRUMENTS AND ACCESSORIES USER MANUAL 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 IN ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN YAW PULLEY FOUND DURING FAILURE ANALYSIS IF TO RECUR COULD CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A DA VINCI HYSTERECTOMY SURGICAL PROCEDURE, A BROKEN/FRAYED CABLE WAS OBSERVED ON THE MARYLAND BIPOLAR FORCEPS INSTRUMENT. THERE WAS NO REPORT OF FRAGMENTS FALLING INTO A PATIENT. THERE WAS NO PATIENT HARM, ADVERSE OUTCOME OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384134 MARYLAND BIPOLAR FORCEPS INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 420172-07 M10110805 734

    Patients

    Seq Age Sex Outcome Treatment
    1