BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK AUTO ENDO 05 APPLIER

    MDR report key: 2934724 · Received January 23, 2013

    Report

    Report Number
    3003898360-2013-00030
    Event Type
    Malfunction
    Date Received
    January 23, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 8, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE NOT REC'D BY MFR IN TIME FOR THIS REPORT. DHR REVIEW DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, HOWEVER THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: CLIP APPLICATOR JAMMED ON CYSTIC DUCT AND COULD NOT BE EASILY REMOVED. DEVICE WAS EVENTUALLY REMOVED AND A NEW APPLICATOR WAS USED TO FINISH THE PROCEDURE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33424 WECK AUTO ENDO 05 APPLIER AUTOMATIC CLIP APPLIER FZP TELEFLEX MEDICAL 011200029

    Patients

    Seq Age Sex Outcome Treatment
    1