BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1062092 · Received June 18, 2008

    Report

    Report Number
    3005099803-2008-00736
    Event Type
    Injury
    Date Received
    June 18, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNW
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE WILL BE RETURNED FOR EVAL, THE DEVICE HAS NOT BEEN RECEIVED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE; THE RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    DURING BIOPSY PROCEDURE, THE TISSUE WELL OF STOMACH WAS UNABLE TO BITE OFF WITH THE RADIAL JAW 3 BIOPSY FORCEPS. THE PT'S CONDITION WAS REPORTED TO BE GOOD. ADDITIONAL INFO WAS RECEIVED DURING THE FOLLOW-UP: WHILE USING THE SCOPE, A LITTLE BLEEDING WAS FOUND, BUT BLEEDING WAS STOPPED WITHOUT PROBLEM. THE BLEEDING WAS POSSIBLY CAUSED BY THE INABILITY TO BITE OFF THE TISSUE PROPERLY. IT IS SUSPECTED THE CUPS WERE NOT ABLE TO CUT OFF ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS PCL KNW BOSTON SCIENTIFIC CORPORATION M00515362 11304524

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other