BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO APPLIER 5 M/L

    MDR report key: 1854010 · Received September 2, 2010

    Report

    Report Number
    3003898360-2010-00398
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Date of Event
    August 1, 2010
    Report Date
    August 26, 2010
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR HAS NOT RECEIVED THE SAMPLE FOR INVESTIGATION AT THIS TIME. THE RESULTS OF THE INVESTIGATION ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP INVESTIGATION REPORT WILL BE SENT WHEN COMPLETED.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: DURING A NEPHRECTOMY, THE APPLIER WOULD NOT RELEASE THE CLIP. THIS IS THE SECOND INCIDENT. THE SURGEON HAD TO USE THE NEEDLE AND WIRE. NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTO ENDO APPLIER 5 M/L ENDO APPLIER GDO TELEFLEX MEDICAL NA 01D100309

    Patients

    Seq Age Sex Outcome Treatment
    1