BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID FIRE

    MDR report key: 855177 · Received March 10, 2007

    Report

    Report Number
    1223688-2007-00002
    Event Type
    Malfunction
    Date Received
    March 10, 2007
    Report Date
    February 7, 2007
    Manufacturer
    CONMED ENDOSCOPIC TECHNOLOGIES, INC.
    Product Code
    FHN
    PMA / PMN Number
    K971137
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS INCONCLUSIVE. THE DEVICE WAS FOUND TO BE UNCONFIRMED FOR THE REPORTED CONDITION. VISUAL INSPECTION REVEALED THAT THE THREADING WAS NOT BROKEN. A DHR REVIEW WAS PERFORMED. REVIEW OF THE RECORDS SHOWED NO NCR'S (NONCONFORMANCE REPORTS) OR ANY TYPE OF DEVIATIONS ASSOCIATED WITH THE LOT NUMBER. NO CAPA WILL BE INITIATED AS COMPLAINT WAS FOUND TO BE UNCONFIRMED FOR THE REPORTED CONDITION.

    Description of Event or Problem · 1

    DEVICE #1: TWO DEVICES WERE USED IN THE PROCEDURE ON THE SAME PATIENT. THE DEVICE MISFIRED ALL 5 BANDS AND THREADING BROKE. THE PROCEDURE WAS NOT COMPLETED AND THE PATIENT WILL BE RESCHEDULED FOR ANOTHER PROCEDURE WHEN THE DOCTOR RETURNS TO THE FACILITY. THERE WAS NO PATIENT HARM. REFER TO MFR REPORT #1223688-2007-00003 FOR INFORMATION REGARDING DEVICE #2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAPID FIRE LIGATOR FHN CONMED ENDOSCOPIC TECHNOLOGIES, INC. NA ETPEW002

    Patients

    Seq Age Sex Outcome Treatment
    1 *