BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 BIOPSY FORCEPS

    MDR report key: 1222894 · Received November 6, 2008

    Report

    Report Number
    3005099803-2008-06126
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    DEVICE 2 OF 3. DURING THE COLONOSCOPY PROCEDURE, A RADIAL JAW 3 BIOPSY FORCEPS WERE USED. THE FORCEPS DID NOT FIRE WHEN THE TISSUE WAS GRABBED. THE FORCEPS WOULD GRAB THE TISSUE BUT THE DEVICE WOULD NOT FIRE. THE PHYSICIAN ATTEMPTED TO USE TWO OTHER RADIAL JAW 3 BIOPSY FORCEPS. THE SAME EVENT REPEATED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. REFER TO ASSOCIATED MANUFACTURER REPORT # 3005099803-2008-06125 AND 3005099803-2008-06127 FOR A DESCRIPTION OF THE OTHER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIAL JAW 3 BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515502 11139424

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK