BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OLYMPUS HF RESECTION ELECTRODE, LOOP

    MDR report key: 4143572 · Received August 8, 2014

    Report

    Report Number
    2951238-2014-00298
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 21, 2014
    Manufacturer
    OLYMPUS WINTER AND IBE GMBH
    Product Code
    FAS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REFERRED TO IN THIS REPORT HAS NOT BEEN RETURNED TO OLYMPUS FOR EVAL. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AT THIS TIME. OLYMPUS WILL CONTINUE TO WORK WITH THE USER FACILITY TO OBTAIN MORE DETAILED INFO REGARDING THIS REPORT, AND IF NEW INFO IS RECEIVED AT A LATER TIME THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    OLYMPUS RECEIVED A MEDWATCH REPORT STATING THAT THE TIP OF THREE ELECTRODES BROKE OFF DURING A CASE. THERE WAS NO PT HARM REPORTED. OLYMPUS FOLLOWED UP WITH THE USER FACILITY VIA PHONE AND IN WRITING IN AN EFFORT TO OBTAIN ADDITIONAL INFO REGARDING THE REPORTED EVENT WITH NO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470561 OLYMPUS HF RESECTION ELECTRODE, LOOP RESECTION ELECTRODE FAS OLYMPUS WINTER AND IBE GMBH A22206C 13319P02L001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other A22206C WITH LOT 13319P02L001 (2951238-2014-00298)| A22206C WITH LOT 13319P02L001 (2951238-2014-00297)