BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTION HEMOSTASIS CLIPPING DEVICE

    MDR report key: 1881624 · Received October 25, 2010

    Report

    Report Number
    3005099803-2010-04439
    Event Type
    Malfunction
    Date Received
    October 25, 2010
    Date of Event
    August 2, 2010
    Report Date
    October 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MND
    PMA / PMN Number
    K040148
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS AS OF YET. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RESOLUTION CLIP DEVICE WAS USED DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PERFORMED ON (B)(6) 2010. IT HAS BEEN REPORTED THAT THE CUSTOMER CAN NOT RECALL THE MALFUNCTION/DEFECT OF THE CLIP. BASED ON THE AMBIGUITY OF THE EVENT THE PRIORITY WAS DEEMED A MALFUNCTION AND THE EVENT REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTION HEMOSTASIS CLIPPING DEVICE LIGATOR, ESOPHAGEAL MND BOSTON SCIENTIFIC - MARLBOROUGH M00522610

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR