BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTO ENDO5 ML

    MDR report key: 9481884 · Received December 17, 2019

    Report

    Report Number
    3003898360-2019-01491
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 11, 2019
    Report Date
    December 2, 2019
    Manufacturer
    TELEFLEX MEDICAL/MORRISVILLE
    Product Code
    FZP
    PMA / PMN Number
    K152081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY REVIEW FOR THE PRODUCT AUTO ENDO5 ML LOT# 73E1900153 INVESTIGATION DID NOT SHOW ISSUES RELATED TO THE COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIRST 4 CLIPS WERE FIRED WITHOUT ISSUE BUT THE CLIP WAS NOT LOADED AFTER 4 SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272830 AUTO ENDO5 ML CLIP, IMPLANTABLE FZP TELEFLEX MEDICAL/MORRISVILLE 73E1900153

    Patients

    Seq Age Sex Outcome Treatment
    1