BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1213835 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05363
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE DETERMINATION OF A ROOT CAUSE MAY NOT BE COMPLETED WITHOUT ANALYSIS OF THE DEVICE INVOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ESOPHAGOGASTRODUODENOSCOPY WITH BIOPSY OF THE ESOPHAGUS, THE RADIAL JAW 3 BIOPSY FORCEPS JAWS WOULD NOT CLOSE. THE FORCEPS WERE ABLE TO OPEN TO TAKE THE BITE BUT THEY WOULD NOT CLOSE. THE CASE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515993 0011778309

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR