BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-CABLE, MONOPOLAR, 4 M, UES-30/-40,

    MDR report key: 5802935 · Received July 19, 2016

    Report

    Report Number
    2951238-2016-00601
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 20, 2016
    Report Date
    November 14, 2016
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    DSA
    PMA / PMN Number
    PK944201
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO OLYMPUS FOR EVALUATION. THE CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED; HOWEVER, USER HANDLING COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR. THE INSTRUCTION MANUAL CONTAINS SEVERAL WARNING STATEMENTS IN AN EFFORT TO PREVENT DAMAGE TO THE CABLE. ¿VISUALLY INSPECT THE CABLE AND THE PLUGS FOR IRREGULARITIES ON THE SURFACE. DO NOT USE A CABLE WITH BRITTLE OR DEFECTIVE INSULATION. REPLACE THE CABLE. IN ORDER TO PLUG OR UNPLUG THE CABLE ALWAYS PULL AT THE PLUG. NEVER PULL AT THE CABLE.¿

    Additional Manufacturer Narrative · 1

    THE HIGH FREQUENCY (HF) CABLE WAS RETURNED TO OLYMPUS FOR EVALUATION. THE EVALUATION WAS UNABLE TO CONFIRM THE REPORTED EVENT. AN OLYMPUS TEST WORKING ELEMENT ((B)(4)) AND TEST GENERATOR ((B)(4)) WAS ATTACHED TO THE HF CABLE, AND THERE WAS A CONSISTENT ENERGY OUTPUT NOTED AT THE DISTAL END DURING ACTIVATION. NO ABNORMALITIES NOTED. IN ADDITION, NO SMOKE OR ARCING WAS OBSERVED DURING ACTIVATION. BASED ON THE INVESTIGATION FINDINGS, THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED AS THE HF CABLE FUNCTIONED AS DESIGNED WITH NO ABNORMALITIES.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP) PROCEDURE, THE HIGH FREQUENCY (HF) CABLE SPARKED AND SMOKED. THERE WAS NO INJURY TO THE USER OR PATIENT. NO EMERGENCY FIRE EVACUATION TOOK PLACE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT HF CABLE. THIS IS REPORT 3 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457192 HF-CABLE, MONOPOLAR, 4 M, UES-30/-40, HF CABLE DSA OLYMPUS WINTER & IBE GMBH A0393 342998

    Patients

    Seq Age Sex Outcome Treatment
    1