BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1222896 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06124
    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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURING FACILITY FOR THE EVAL.

    Description of Event or Problem · 1

    DURING THE COLONOSCOPY PROCEDURE, A RADIAL JAW 3 BIOPSY FORCEP WAS USED. THE FORCEPS DID NOT FIRE WHEN THE TISSUE WAS GRABBED. THE FORCEPS WOULD GRAB THE TISSUE BUT THE DEVICE WOULD NOT FIRE. THE SNARE WAS USED TO COMPLETE THE PROCEDURE. THE PT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515502 11139424

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK