BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIAL JAW 3 SINGLE - USE BIOPSY FORCEPS

    MDR report key: 1171410 · Received September 17, 2008

    Report

    Report Number
    3005099803-2008-04664
    Event Type
    Malfunction
    Date Received
    September 17, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER (DIFFICULTY ACTUATING DEVICE). THESE CODES WERE SELECTED BY THE MANUFACTURER BASED ON INFORMATION OBTAINED FROM THE USER FACILITY. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISCARDED. A DEVICE EVALUATION CANNOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR THIS LOT WAS REVIEWED; NO ANOMALIES WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT A RADIAL JAW 3 SINGLE - USE BIOPSY FORCEPS WAS USED DURING A PROCEDURE PERFORMED THE DAY BEFORE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN HAD DIFFICULTY "OPENING THE JAWS" OF THE DEVICE. DESPITE THE DIFFICULTY, THE PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE WITH THIS 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 RADIAL JAW 3 SINGLE - USE BIOPSY FORCEPS FCL BOSTON SCIENTIFIC CORPORATION M00515993 0011296568

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK