BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILATERAL DOUBLE BALLOON SET

    MDR report key: 795425 · Received December 7, 2006

    Report

    Report Number
    9611612-2006-00005
    Event Type
    Malfunction
    Date Received
    December 7, 2006
    Manufacturer
    PAJUNK GMBH MEDIZINTECHNOLOGIE
    Product Code
    KOG
    PMA / PMN Number
    k012771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS APPROVED IN THE US (K012771), BUT HAS NOT BEEN MARKETED YET. NO DEVICE HAS BEEN IMPORTED TO THE US.

    Description of Event or Problem · 1

    BALLOON BURST INSIDE THE PT. WAS NOT OVERINFLATED. BALLOON THAT BURST WAS 1285-30-11 (PART OF 1285-50-20). REFERRING TO PHYSICIANS STATEMENT THE PT IS DOING WELL. THE BALLOONS ARE TESTED 100% DURING MANUFACTURING. PAJUNK AS THE MFR IS TESTING SEVERAL DEVICES FROM THE SAME MANUFACTURING AND STERILIZATION BATCH. VALID RESULTS WILL BE AVAILABLE IN JANUARY 2007. OUR EXPERIENCE IS BALLOONS DO NOT BURST BECAUSE OF DEVICE MALFUNCTION OR OVERINFLATION. TEST RESULTS ARE PROMISING. USUALLY, SHARP OR COAGULATING INSTRUMENTS LEAD TO A DETERIORATION OF THE DEVICE. WARNING NOTICES ARE INCLUDED IN THE USER MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILATERAL DOUBLE BALLOON SET 876.1500, ENDOSCOPE, ACCESSORIES K012771 KOG PAJUNK GMBH MEDIZINTECHNOLOGIE * 677

    Patients

    Seq Age Sex Outcome Treatment
    1 *