BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINA LOOP

    MDR report key: 1970470 · Received January 19, 2011

    Report

    Report Number
    3007699067-2011-00006
    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
    KNF
    PMA / PMN Number
    K070351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE MET SPECIFICATIONS BASED ON THE LOT CODE INVESTIGATION. 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, THREE LINA LOOPS BROKEN AT THE TIP WHEN TESTED TOUCHING THE FUNDUS OF THE UTERUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINA LOOP MONOPOLAR ENDOSCOPIC LOOP KNF LINA MEDICAL POLSKA SP. Z.O.O 09121

    Patients

    Seq Age Sex Outcome Treatment
    1