BEUDAMED
    FDA Adverse Event Other Summary report: N

    CUTTING LOOP

    MDR report key: 2445527 · Received February 3, 2012

    Report

    Report Number
    3006159227-2012-00001
    Event Type
    Other
    Date Received
    February 3, 2012
    Date of Event
    December 19, 2011
    Report Date
    January 4, 2012
    Manufacturer
    GYRUS ACMI, 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

    THIS DEVICE IS CURRENTLY STILL UNDER INVESTIGATION AND TESTING AT OUR FACILITY. AS A RESULT, A DETERMINATION CANNOT BE MADE AT THIS TIME. WHEN FURTHER INFO BECOMES AVAILABLE, GYRUS ACMI WILL CONTINUE THE INVESTIGATION AND UPDATE THE AGENCY ACCORDINGLY.

    Description of Event or Problem · 1

    DURING A TURP PROCEDURE TWO LOOPS OF THE SAME LOT NUMBER BROKE INSIDE THE PT, NO PIECES FELL INTO THE PT. A THIRD LOOP WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO HARM TO THE PT. (SEE MFR. REPORT # 3006159227-2012-00003 FOR THE SECOND DEVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CUTTING LOOP CUTTING LOOP HIH GYRUS ACMI, INC. MLE-24-012 356891HD

    Patients

    Seq Age Sex Outcome Treatment
    1