BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE

    MDR report key: 4548067 · Received February 19, 2015

    Report

    Report Number
    9610773-2015-00007
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    February 2, 2015
    Report Date
    February 3, 2015
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KNS
    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 HEAVILY DEFORMED AND TWISTED FORK TUBES. FURTHERMORE, THE LOOP WIRE IS DAMAGED/BROKEN AND ALSO 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 TRANSCERVICAL RESECTION (TCR) PROCEDURE, THE LOOP WIRE OF THE SUSPECT MEDICAL DEVICE SPARKED, BROKE OFF AND FELL INSIDE THE PT. HOWEVER, NO FRAGMENTS/PARTS REMAINED INSIDE THE PT AS THEY WERE REPORTEDLY RETRIEVED BY UNK APPROACH. 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
    119406 HF-RESECTION ELECTRODE, LOOP, 24 FR., 0.35 WIRE HF-RESECTION ELECTRODES KNS OLYMPUS WINTER & IBE GMBH 13144P03L002

    Patients

    Seq Age Sex Outcome Treatment
    1