BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1202101 · Received October 16, 2008

    Report

    Report Number
    3005099803-2008-05324
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 12, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RADIAL JAW 3 BIOPSY FORCEPS CUP BROKE. THE NURSE CHECKED THE PRODUCT BEFORE IT WAS INTRODUCED INTO THE ENDOSCOPE AND IT WAS PERFECT TO USE. THE FORCEPS WERE PASSED DOWN THE ENDOSCOPE AND WHEN EXITED THE NURSE NOTICED THAT THE FORCEPS CUP APPEARED DAMAGED. THE FORCEPS WERE WITHDRAWN AND INSPECTED; THE CUP WAS DAMAGED. THE ENDOSCOPE WAS REMOVED FROM THE PATIENT AND A CLEANING BRUSH PUSHED DOWN THE CHANNEL, A SMALL PIECE OF THE FORCEPS CUP FELL OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE; THE PATIENT 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 M00515992 0011775350

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK