BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK AUTO ENDO5 ML

    MDR report key: 3966489 · Received June 26, 2014

    Report

    Report Number
    3003898360-2014-00397
    Event Type
    Malfunction
    Date Received
    June 26, 2014
    Date of Event
    March 5, 2014
    Report Date
    June 6, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW NAY ISSUES RELATED TO HIS COMPLAINT. DEVICE SAMPLE RECEIVED BY MFR, BUT INVESTIGATION IS STILL UNDERWAY AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES THAT A CLIP GOT STUCK AND WAS NOT LOADED INTO THE JAWS." THERE WAS NO CONSEQUENCES TO THE PT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373794 WECK AUTO ENDO5 ML CLIP APPLIER GDO TELEFLEX MEDICAL 01H1300053

    Patients

    Seq Age Sex Outcome Treatment
    1