BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RJ4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY

    MDR report key: 1230453 · Received November 7, 2008

    Report

    Report Number
    3005099803-2008-06147
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Report Date
    October 10, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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

    NOTE: THE DATE OF EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BENT NEEDLE OF A RADIAL JAW 4 LARGE CAPACITY BIOPSY FORCEPS DEVICE PROTRUDED BEYOND THE FORCEPS JAWS. ACCORDING TO THE COMPLAINANT, THE PROCEDURE WAS COMPLETED WITH ANOTHER RADIAL JAW 4 LARGE CAPACITY BIOPSY FORCEPS DEVICE. 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 "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RJ4 SINGLE USE BIOPSY FORCEPS LARGE CAPACITY FCL BOSTON SCIENTIFIC CORPORATION M00513332 0011925445

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR