BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 4 BIOPSY FORCEPS

    MDR report key: 1192504 · Received September 26, 2008

    Report

    Report Number
    3005099803-2008-04878
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    August 25, 2008
    Report Date
    August 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING THE ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN NOTICED THE NEEDLE ON THE RADIAL JAW 4 BIOPSY FORCEPS WAS BENT. THE FORCEPS WERE PUT DOWN THE SCOPE, WHEN THE JAWS WERE OPENED, THE PHYSICIAN NOTICED THE NEEDLE WAS BENT AT 90 DEGREES; STICKING STRAIGHT OUT THE SIDE OF THE JAWS. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. PT IS REPORTED TO BE "FINE". THE CUSTOMER IS HAVING THE SCOPE TESTED TO ENSURE THERE WAS NO DAMAGE. ADDITIONALLY, IT WAS REPORTED THE PACKAGE WAS NOT DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 4 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00513332 0011767846

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK