BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 PULMONARY BIOPSY FORCEPS

    MDR report key: 1222867 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06100
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    September 23, 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 MANUFACTURE 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 WHILE ATTEMPTING TO RETRIEVE A SAMPLE WITH A RADIAL JAW 3 PULMONARY BIOPSY FORCEPS DEVICE, THE PHYSICIAN NOTICED THAT THE JAW WAS BENT. THE DEVICE AND THE ENDOSCOPE WERE REMOVED TOGETHER. THE FORCEPS WERE OPENED OUTSIDE PATIENT TO RETRIEVE SAMPLE AND THE DEVICE WAS STRAIGHTENED AND REMOVED FROM ENDOSCOPE. PROCEDURE COMPLETED WITH ANOTHER OF SAME RADIAL JAW 3 PULMONARY BIOPSY FORCEPS. 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 58 YR