BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WECK HEM-O-LOK ENDO APPLIER XL

    MDR report key: 2062523 · Received March 21, 2011

    Report

    Report Number
    1044475-2011-00032
    Event Type
    Malfunction
    Date Received
    March 21, 2011
    Date of Event
    January 7, 2011
    Report Date
    February 25, 2011
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    FZP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT HAS NOT YET BEEN RECEIVED BY MANUFACTURER, THEREFORE, INVESTIGATION REPORT IS INCOMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE APPLIER REMAINED ATTACHED TO THE CLIP DURING REMOVAL. THE ALLEGED INCIDENT OCCURRED DURING A LAPAROSCOPY NEPHRECTOMY. THE SURGEON HAD TO MANIPULATE BY MOVING THE LAPAROSCOPIC INSTRUMENTS IN ORDER TO RELEASE THE CLIPS. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WECK HEM-O-LOK ENDO APPLIER XL HEM-O-LOK ENDO APPLIER FZP TELEFLEX MEDICAL NA 3015065

    Patients

    Seq Age Sex Outcome Treatment
    1