BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, LOOP, 22.5 FR., 0.35 WIRE, 12°

    MDR report key: 5867905 · Received August 11, 2016

    Report

    Report Number
    9610773-2016-00037
    Event Type
    Malfunction
    Date Received
    August 11, 2016
    Date of Event
    July 7, 2016
    Report Date
    August 11, 2016
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    KNS
    PMA / PMN Number
    K903323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT MEDICAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION/INVESTIGATION BUT TO OLYMPUS MEDICAL SYSTEMS CORPORATION (OMSC), (B)(4). THE EVALUATION/INVESTIGATION CONFIRMED THAT THE HF RESECTION ELECTRODE IS DAMAGED AND BROKEN. THE LOOP WIRE AT THE DISTAL END IS BROKEN OFF COMPLETELY AND MISSING. FURTHERMORE, THERE ARE CHARRED STAINS AT THE PARTIALLY MELTED GREEN WIRE INSULATION OF BOTH FORK TUBES, WHICH ARE SEVERELY BENT. THE CAUSE OF THIS DAMAGE AND THE BREAKAGE OF THE LOOP WIRE IS MECHANICAL OVERLOAD BY THE APPLICATION OF EXCESSIVE FORCE AND LONG-TERM USE OF THE HF RESECTION ELECTRODE (DATE OF MANUFACTURE: 04/2014). THEREFORE, THIS EVENT/INCIDENT WAS ATTRIBUTED TO ABNORMAL USE/OFF-LABEL USE IN COMBINATION WITH EXCEEDED SERVICE LIFE. THE CASE WILL BE CLOSED FROM OLYMPUS SIDE WITH NO FURTHER ACTIONS. HOWEVER, THE EVENT/INCIDENT WILL BE RECORDED FOR TRENDING AND SURVEILLANCE PURPOSES AND THE USER WILL BE INFORMED ABOUT THE INVESTIGATION RESULTS AND PRO RE NATA RETRAINED TO CORRECTLY USE THE OLYMPUS MEDICAL DEVICES.PLEASE NOTE: THIS REPORT IS BEING SUBMITTED ALTHOUGH THE SUSPECT MEDICAL DEVICE IS NOT MARKETED IN THE USA. HOWEVER, A SIMILAR DEVICE IS MARKETED. MODEL # / CATALOG #: WA47050C; BRAND NAME: HF-RESECTION ELECTRODE, LOOP, 22.5 FR., 0,35 WIRE, 12°, STERILE, SINGLE USE, 12 PCS.; COMMON DEVICE NAME: HF-RESECTION ELECTRODES; 510(K): K903323; PRODUCT CODE: KNS.

    Description of Event or Problem · 1

    OLYMPUS WAS INFORMED THAT WHILE CLEANING AFTER A THERAPEUTIC TRANSCERVICAL RESECTION (TCR) PROCEDURE, IT WAS NOTICED THAT THE LOOP WIRE AT THE DISTAL END OF THE HF RESECTION ELECTRODE HAD BROKEN OFF AND WAS MISSING. AN X-RAY WAS TAKEN THE NEXT DAY, WHERE THE LOOP WIRE WAS FOUND INSIDE THE PATIENT'S UTERUS. IT WAS DECIDED TO WATCH AND WAIT FOR THE LOOP WIRE TO BE EXCRETED NATURALLY. HOWEVER, A FOLLOWUP HYSTEROSCOPY PROCEDURE HAS SINCE BEEN SCHEDULED TO RETRIEVE THE LOOP WIRE WHICH WAS NOT EXCRETED AFTER ALL. NO FURTHER INFORMATION WAS PROVIDED, BUT THERE WAS NO ADVERSE EVENT OR PATIENT INJURY DURING THE TCR WHICH WAS SUCCESSFULLY COMPLETED WITH THE SAME SET OF EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520053 HF-RESECTION ELECTRODE, LOOP, 22.5 FR., 0.35 WIRE, 12° HF-RESECTION ELECTRODES KNS OLYMPUS WINTER & IBE GMBH WA47050A 14118P03L001

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR