BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINA LOOP

    MDR report key: 1970473 · Received January 19, 2011

    Report

    Report Number
    3007699067-2011-00003
    Event Type
    Malfunction
    Date Received
    January 19, 2011
    Date of Event
    January 1, 2009
    Report Date
    January 15, 2011
    Manufacturer
    LINA MEDICAL POLSKA SP. Z.O.O
    Product Code
    NDN
    PMA / PMN Number
    K070351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED AND THEREFORE, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE MET SPECIFICATIONS OR DETERMINE IN THE CAUSE OF BREAKAGE. THIS REPORT IS BEING SUBMITTED AT THIS TIME DUE TO AN INTERNAL RETROSPECTIVE ANALYSIS INDICATING SOME LIKELIHOOD THAT A LOOP BROKEN IN USE MAY RESULT IN INJURY.

    Description of Event or Problem · 1

    SURGEON REPORTED, FOUR LOOPS BROKEN WHEN ACTIVATED. TWO OF THE FOUR WERE RETURNED FOR ANALYSIS. THIS REPORT IS FOR ONE OF THE TWO THAT WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINA LOOP MONOPOLAR ENDOSCOPIC LOOP NDN LINA MEDICAL POLSKA SP. Z.O.O EL-160-08

    Patients

    Seq Age Sex Outcome Treatment
    1