BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE

    MDR report key: 4548065 · Received February 19, 2015

    Report

    Report Number
    9610773-2015-00008
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    January 22, 2015
    Report Date
    January 27, 2015
    Manufacturer
    OLYMPUS WINTER AND IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MFR FOR EVAL/INVESTIGATION BUT TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), (B)(4). THE EVAL/INVESTIGATION FOUND THE HF RESECTION ELECTRODE WITH DEFORMED FORK TUBES. FURTHERMORE, THE LOOP WIRE IS DAMAGED/BROKEN AND HEAVILY DEFORMED. CAUSAL FOR THIS DAMAGE AND THE SUBSEQUENT BREAKAGE OF THE LOOP WIRE IS MECHANICAL OVERLOAD BY THE APPLICATION OF EXCESSIVE FORCE. THEREFORE, THIS INCIDENT WAS ATTRIBUTED TO ABNORMAL USE/OFF-LABEL USE AND THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES AND THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS AND PRO RE NATA TRAINED AGAIN ON THE CORRECT USAGE OF THE OLYMPUS MEDICAL DEVICES. OLYMPUS SUBMITS THIS INCIDENT AS A MEDICAL DEVICE REPORT (MDR) IN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT DURING AN UNSPECIFIED THERAPEUTIC TRANSURETHRAL RESECTION (TUR) PROCEDURE, THE LOOP WIRE OF THE SUSPECT MEDICAL DEVICE BROKE INSIDE THE PT. HOWEVER, NO FRAGMENTS/PARTS FELL OFF. THE INTENDED PROCEDURE WAS SUBSEQUENTLY COMPLETED BY USING ANOTHER SIMILAR DEVICE. NO OTHER INFO WAS PROVIDED BUT THERE WAS NO REPORT ABOUT AN ADVERSE EVENT OR PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118877 HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.2 WIRE HF-RESECTION ELECTRODES FAS OLYMPUS WINTER AND IBE GMBH 13217P03L001

    Patients

    Seq Age Sex Outcome Treatment
    1