BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUTTING LOOP

    MDR report key: 2431527 · Received January 26, 2012

    Report

    Report Number
    3006159227-2012-00002
    Event Type
    Other
    Date Received
    January 26, 2012
    Date of Event
    December 19, 2011
    Report Date
    January 4, 2012
    Manufacturer
    GYRUS MEDICAL, INC.
    Product Code
    HIH
    PMA / PMN Number
    K890328
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE IS BEING RETURNED FOR EVALUATION. AS STATED THE MONOPOLAR ELECTRODE (MLE-26-012) WAS BEING USED WITH A SALINE IRRIGATION SOLUTION. AS SPECIFIED IN THE IFU (99-1082 REV BB) WARNING 10. USE ONLY NONCONDUCTIVE IRRIGATION SOLUTIONS, DO NOT USE SALINE OR LACTATED RINGERS. FAILURE OF DEVICE HAS BEEN DETERMINED TO BE USER CAUSED. IF FURTHER INFORMATION BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A PROCEDURE THE PATIENT WAS TREATED WITH A LOWER UTERINE FIBROID AND ACMI SLIMLINE DIAGNOSTIC HYSTEROSCOPE WAS USED WITH SALINE. ACMI MONOPOLAR RESECTOSCOPE WAS USED WITH THE SALINE AND ELECTRODE LOOP WOULD NOT IGNITE. THERE WAS NO PATIENT INJURY BUT THE PROCEDURE WAS NOT COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING LOOP CUTTING LOOP HIH GYRUS MEDICAL, INC. MLE-26-012 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1