BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 APPLIER

    MDR report key: 3956959 · Received June 18, 2014

    Report

    Report Number
    3003898360-2014-00381
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 2014
    Manufacturer
    TELEFLEX
    Product Code
    HBT
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW (DHR) OF THE AUTO ENDO5 ML, LOT NUMBER 01K1300424 WAS MANUFACTURED ON 10/25/2013 A TOTAL OF 288 PIECES. LOT WAS RELEASED ON 10/25/2013. THE DHR INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE SAMPLE WAS RECEIVED BY THE MANUFACTURER, BUT THE INVESTIGATION IS STILL UNDERWAY AT THE TIME OF THIS REPORT. THE MANUFACTURER WILL CONTINUE TO MONITOR, TREND RELATED COMPLAINTS.

    Description of Event or Problem · 1

    ALLEGED ISSUE: IT WAS REPORTED THAT THE FIRST 2 CLIPS CAME OUT CORRECTLY BUT THE REST OF THE CLIPS CAME OUT IN A CLOSED POSITION. THERE WAS NO PATIENT INJURY OR CONSEQUENCES REPORTED. PATIENT CONDITION REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358436 AUTO ENDO5 APPLIER APPLIER HBT TELEFLEX 01K1300424

    Patients

    Seq Age Sex Outcome Treatment
    1