BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINA LOOP

    MDR report key: 2010823 · Received January 19, 2010

    Report

    Report Number
    3007699067-2011-00008
    Event Type
    Injury
    Date Received
    January 19, 2010
    Date of Event
    January 29, 2010
    Report Date
    January 15, 2011
    Manufacturer
    LINA MEDICAL POLSKA SP. Z.O.O
    Product Code
    KNF
    PMA / PMN Number
    K070351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A LAPAROSCOPY SUPRA CERVICAL HYSTERECTOMY USING A LINA LOOP, THE PT SUSTAINED A COMPLETE TRANSECTION OF HER LEFT URETER. THE LINA LOOP HAD BEEN APPLIED AT THE UTERINE ARTERY LEVEL AND THE UTERINE BODY WAS COMPLETELY TRANSECTED FROM THE CERVIX. AFTER COMPLETE MORCELLATION OF THE UTERUS AND FIBROIDS, A COMPLETELY TRANSECTED LEFT URETER WAS IDENTIFIED AND REPAIRED.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other