BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HORIZON ML ENDO APPLIER

    MDR report key: 2971546 · Received January 31, 2013

    Report

    Report Number
    1044475-2013-00020
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 21, 2013
    Manufacturer
    TELEFLEX
    Product Code
    FZP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE SAMPLE NOT RETURNED TO MANUFACTURER AT TIME OF THIS REPORT. INVESTIGATION IS INCOMPLETE AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: ALLEGED ISSUE: DURING A NEPHRECTOMY, THE CLIP REMAINED BLOCKED IN THE APPLIER AND ON THE VESSEL. THE SURGEON REMOVED THE CLIP AND USED ANOTHER ONE. NO REPORTED PATIENT INJURY. CURRENT PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43560 HORIZON ML ENDO APPLIER LIGATING APPLIER FZP TELEFLEX

    Patients

    Seq Age Sex Outcome Treatment
    1