BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOC PLUS ENDOTOUCH APPLIER 13" CURVED

    MDR report key: 3532844 · Received October 24, 2013

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    Report

    Report Number
    1044475-2013-00189
    Event Type
    Malfunction
    Date Received
    October 24, 2013
    Date of Event
    August 30, 2013
    Report Date
    October 8, 2013
    Manufacturer
    TELEFLEX
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS RECEIVED BY MANUFACTURER BUT INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: THERE WAS A PROBLEM WITH THE JAWS OF THE APPLIER OPENING AND CLOSING. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547757 HOC PLUS ENDOTOUCH APPLIER 13" CURVED CLIP APPLIER FZP TELEFLEX 0540697

    Patients

    Seq Age Sex Outcome Treatment
    1