BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1222890 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06130
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    DURING COLONOSCOPY PROCEDURE A RADIAL JAW 3 BIOPSY FORCEPS WAS USED. THE PHYSICIAN WAS ABLE TO TAKE A TISSUE SAMPLE BUT AS HE WAS EXTRACTING THE FORCEPS IT TURNED IN ON ITSELF AND GOT CAUGHT INSIDE THE BIOPSY CHANNEL. THE PT'S CONDITION IS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515993 0011865697

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR