BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINA LOOP

    MDR report key: 2613202 · Received February 17, 2010

    Report

    Report Number
    3007699067-2010-00010
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    December 22, 2009
    Report Date
    January 26, 2010
    Manufacturer
    LINA MEDICAL POLSKI SP. Z.O.O.
    Product Code
    KNF
    PMA / PMN Number
    K070315
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY A LINA LOOP WAS INSERTED THE FIRST TIME AND THE HANDLE ADVANCED TO EXTEND THE LOOP. WHEN EXTENDED THE LOOP DIDN'T OPEN CORRECTLY. IT WAS TWISTED. THE SURGEON REMOVED THE LOOP, ADVANCED IT OUTSIDE THE PT AND IT OPENED CORRECTLY. THE LOOP WAS INSERTED IN THE PT A SECOND TIME, POSITIONED IT AROUND THE UTERINE BODY, ACTIVATED THE ELECTROSURGICAL GENERATOR FOOTSWITCH AND THE LOOP BROKE. THE BROKEN LOOP WAS REMOVED AND A NEW LOOP WAS USED TO COMPLETE AMPUTATION OF THE UTERINE BODY. THE PROCEDURE WAS EXTENDED BY ABOUT 10 MINS DURING WHICH TIME THE SURGEON INSPECTED THE BROKEN LOOP TO CONFIRM NO PIECES WERE LEFT IN THE PT AND INSPECTED THE PT LOOKING FOR BURNS OR LACERATIONS. THERE WERE NO BURNS OR LACERATIONS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINA LOOP MONOPOLAR ENDOSCOPIC LOOP KNF LINA MEDICAL POLSKI SP. Z.O.O. EL-200-8 08385

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR