BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML APPLIER

    MDR report key: 4092560 · Received August 19, 2014

    Report

    Report Number
    3003898360-2014-00564
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 11, 2014
    Report Date
    August 4, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    HBT
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ANY ISSUES RELATED TO THIS COMPLAINT. NO CORRECTIVE ACTIONS CAN BE ESTABLISHED SINCE IT IS NECESSARY TO RECEIVE THE PHYSICAL SAMPLE TO PERFORM A PROPER INVESTIGATION AND CONFIRM THE DEFECT. AT THIS TIME DUE TO THE LACK OF DEFECTIVE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE THE SOURCE OF THE DEFECT REPORTED. MFR WILL CONTINUE TO MONITOR AND TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: THE FACILITY WAS UNABLE TO LOAD CLIPS FROM THE JAW. THIS OCCURRED DURING ON A PT. NO PT INJURY REPORTED. ADD'L INFO WAS REQUESTED; HOWEVER, CLARIFICATION OF THE EVENT WAS NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500199 AUTO ENDO5 ML APPLIER APPLIUER HBT TELEFLEX MEDICAL 01E1300025

    Patients

    Seq Age Sex Outcome Treatment
    1