BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1203279 · Received October 17, 2008

    Report

    Report Number
    3005099803-2008-05361
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    DURING BIOPSY PROCEDURE RADIAL JAW 3 BIOPSY FORCEPS WERE USED. IT WAS REPORTED THAT THE FORCEP WAS DIFFICULT TO WITHDRAW. IT WAS BLOCKED INSIDE THE WORKING CHANNEL OF ENDOSCOPE. THE ENTIRE DEVICE WAS REMOVED FROM THE ENDOSCOPE, BUT IT WAS NOT ALIGNED AND THE JAWS WERE LITTLE OPENED. THE ENDOSCOPE WAS NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515362 11632309

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK