BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINA LOOP

    MDR report key: 1935357 · Received December 16, 2010

    Report

    Report Number
    3007699067-2010-00003
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    October 18, 2010
    Report Date
    December 14, 2010
    Manufacturer
    LINA MEDICAL POLSKA SP. Z.O.O
    Product Code
    KNF
    PMA / PMN Number
    K070351
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND NOT RETURNED FOR FAILURE ANALYSIS. THEREFORE, WE ARE UNABLE TO DETERMINE IF THE DEVICE MET ITS SPECIFICATION. WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT AT THIS TIME. IN ADDITION TO OTHER WARNINGS, CONTRAINDICATIONS, AND INSTRUCTIONS, THE DIRECTIONS FOR USE FOR THE LINA LOOP STATE: "THE LINA GOLD LOOP MUST BE LARGE ENOUGH TO PASS AROUND THE CORPUS OF THE UTERUS. THEN APPLY THE LOOP AROUND THE CERVIX. THE LINA GOLD LOOP SHOULD NOT BE USED WHEN THE ELECTRODE LOOP IS IN CONTACT WITH ANY ORGAN OTHER THAN THE UTERUS. DO NOT ACTIVATE THE LINA GOLD LOOP IF IT IS NOT POSSIBLE TO VISUALIZE THE CUTTING LOOP. START SECTIONING THE UTERINE BODY BY PRESSING "CUT" ON THE FOOT PEDAL. AFTER 1-3 SECONDS, SLOWLY PULL THE HANDLE, UNTIL THE ELECTRODE (LOOP) HAS CUT THE UTERINE BODY AND IS RETRACTED INSIDE THE TUBE."

    Description of Event or Problem · 1

    THE PT UNDERWENT A DA VINCI ROBOT ASSISTED LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY AND SACROCOLPOPEXY BY SURGEON AND COLLEAGUE. THE SURGEON WAS USING A LINA LOOP TO TRANSECT A LARGE FIBROID UTERUS. THE LOOP SLIPPED OFF THE UTERUS AND TRANSECTED THE SMALL BOWEL IN TWO PLACES. A GENERAL SURGEON WAS CALLED IN AND HE REPAIRED THE BOWEL. THE PT HAD AN EXTENDED HOSPITALIZATION IN ORDER FOR HER BOWEL FUNCTION TO RETURN. SHE ALSO HAS LOSS OF SENSATION IN THE LEFT ANTERIOR THIGH. THE LINA LOOP WAS DISCARDED AT THE END OF THE SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R