BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK AUTO ENDO5 ML

    MDR report key: 4823911 · Received June 8, 2015

    Report

    Report Number
    3003898360-2015-00422
    Event Type
    Malfunction
    Date Received
    June 8, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 18, 2015
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GEF
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE HISTORY RECORD (DHR) INVESTIGATION DID NOT SHOW 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 CONFIRM THE COMPLAINT AND TO DETERMINE THE ROOT CAUSE. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: DURING A LAP CHOLE PROCEDURE WHEN THE DOCTOR WAS TRYING TO LOAD CLIPS, THEY DID NOT LOAD SUCCESSFULLY. NO CLICKING SOUND WAS HEARD. NO CLIPS FELL INTO THE PATIENT. NO PATIENT INJURY REPORTED. PATIENT CURRENT CONDITION REPORTED, AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369034 WECK AUTO ENDO5 ML ENDO APPLIER GEF TELEFLEX MEDICAL 73J1400494

    Patients

    Seq Age Sex Outcome Treatment
    1