BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK AUTO ENDO5 ML APPLIER

    MDR report key: 3823743 · Received February 20, 2014

    Report

    Report Number
    3003898360-2014-00083
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    January 24, 2014
    Report Date
    January 27, 2014
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) REVIEW DID NOT SHOW ANY ISSUES RELATED TO THIS COMPLAINT. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. HOWEVER, WE WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: COMPLAINT ALLEGES: SURGEON TRIED TO LOAD THE CLIPS IN THE PRE-LOAD HEMOLOK DEVICE, BUT CLIPS KEPT FALLING OUT OF JAW. HE NOTICED THAT THE JAWS APPEARED TO BE AT AN ANGLE AND THE HINGES STICKING OUT. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106693 WECK AUTO ENDO5 ML APPLIER CLIP APPLIER GDO 01J1300420

    Patients

    Seq Age Sex Outcome Treatment
    1