BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HF-RESECTION ELECTRODE, FOR TURIS

    MDR report key: 16343107 · Received February 9, 2023

    Report

    Report Number
    9610773-2023-00455
    Event Type
    Malfunction
    Date Received
    February 9, 2023
    Date of Event
    January 6, 2023
    Report Date
    February 9, 2023
    Manufacturer
    OLYMPUS WINTER & IBE GMBH
    Product Code
    FAS
    UDI-DI
    14042761051689
    PMA / PMN Number
    K100275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510(K) # - K120418 THE DEVICE WAS RETURNED TO OLYMPUS. IT WAS CONFIRMED THAT THE COVERING TUBE WAS DISPLACED AND THE LOOP WIRE WAS EXPOSED A LITTLE LONGER. IT IS POSSIBLE THAT THE STRENGTH OF THE LOOP WIRE EXPOSED FROM THE COVERING TUBE WAS NOT STABLE AS A CAUSE OF DEFORMATION DURING USE. DISPLACEMENT OF THE COVERING TUBE MAY BE DUE TO MANUFACTURING OR HANDLING, SUCH AS PULLING THE LOOP WIRE STRONGLY WHILE IT IS FIXED TO THE HANDLE. OLYMPUS WILL CONTINUE TO MONITOR THE FIELD PERFORMANCE OF THIS DEVICE.

    Description of Event or Problem · 0

    IN A TUR CASE, THE LOOP ELECTRODE GRADUALLY DEFORMED DURING MUCOSAL INCISION. REPLACED WITH A NEW PRODUCT AND COMPLETED THE PROCEDURE. NO PATIENT EFFECT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1607315 HF-RESECTION ELECTRODE, FOR TURIS ELECTRODE FAS OLYMPUS WINTER & IBE GMBH WA22306D 1000096797 14042761051689

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown