BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 PULMONARY BIOPSY FORCEPS

    MDR report key: 1222869 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06102
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    September 26, 2008
    Report Date
    October 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURER DATE IS UNKNOWN. ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RADIAL JAW 3 PULMONARY BIOPSY FORCEPS DEVICE SUCCESSFULLY ACQUIRED THREE BIOPSY SAMPLES; HOWEVER, THE PHYSICIAN WAS UNABLE TO CAPTURE A FOURTH SAMPLE. AFTER THE DEVICE WSA REMOVED FROM THE PATIENT, THE PHYSICIAN NOTED "AN INCLINATION AT THE JAW" AND PRESUMED THIS TO CAUSE THE INABILITY TO CAPTURE THE BIOPSY SAMPLE; NO ADDITIONAL DAMAGE WAS OBSERVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 PULMONARY BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515230 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR