BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RADIAL JAW 3 SINGLE- USE BIOPSY FORCEPS

    MDR report key: 1162738 · Received September 16, 2008

    Report

    Report Number
    3005099803-2008-04603
    Event Type
    Injury
    Date Received
    September 16, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MFR DATE IS UNK. ALTHOUGH THE COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVAL, IT HAS NOT BEEN RECEIVED. THE DEVICE EVAL HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP IN 2008 THAT A RADIAL JAW 3 SINGLE - USE BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER THE BIOPSY FORCEPS WERE WITHDRAWN FROM THE COLONSCOPE, IT WAS DISCOVERED THAT ONE OF THE JAWS WAS "MISSING". THE DEVICE FRAGMENT WAS RETRIEVED USING A "CLEANING BRUSH" (MFR UNK). THERE WERE NO PT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other