BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW HOT SINGLE-USE BIOPSY FORCEPS

    MDR report key: 1316844 · Received January 9, 2009

    Report

    Report Number
    3005099803-2009-00095
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Date of Event
    December 8, 2008
    Report Date
    December 11, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGE
    PMA / PMN Number
    K910964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 COMPLAINANT HAS INDICATED THAT THE SUSPECT DEVICE IS BEING RETURNED FOR EVALUATION, IT HAS NOT BEEN RETURNED. THE DEVICE EVALUATION HAS NOT BEEN PERFORMED; THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A RADIAL JAW HOT SINGLE-USE BIOPSY FORCEPS WAS USED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, ELECTRICITY WAS RUN TO AN OLYMPUS PSD-60, BUT THE FORCEPS WOULD NOT BURN. THE CUSTOMER INQUIRED AS TO THE COMPATIBILITY OF THE FORCEPS WITH THE PSD-60. PROCEDURE COMPLETED WITH AN OLYMPUS CORPORATION DEVICE (PRODUCT UNKNOWN). 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 HOT SINGLE-USE BIOPSY FORCEPS KGE BOSTON SCIENTIFIC CORPORATION M00515501 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK