BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON SCIENTIFIC CORPORATION

    MDR report key: 1920733 · Received December 7, 2010

    Report

    Report Number
    MW5018519
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FHQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING REPAIR OF A VAGINAL WALL PROLAPSE, DR. (B)(6) REPORTED THAT THE CAPIO SUTURE CAPTURING DEVICES WAS EMITTING A CLICKING SOUND WHILE IT WAS BEING LOADED. THE PHYSICIAN ELECTED NOT TO USE THIS DEVICE AND OPENED/USED ANOTHER WITHOUT INCIDENT. NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC CORPORATION CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE FHQ BOSTON SCIENTIFIC CORPORATION 831-125 12513382

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR