BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-FIBRE KEYCARD

    MDR report key: 3502078 · Received December 2, 2013

    Report

    Report Number
    MW5033223
    Event Type
    Malfunction
    Date Received
    December 2, 2013
    Date of Event
    November 22, 2013
    Report Date
    November 27, 2013
    Manufacturer
    LISA LASER PRODUCTS OHG
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING HYSTEROSCOPY WITH D&C, LYSIS OF ADHESIONS, DIAGNOSTIC LAPAROSCOPY WITH DAVINCI LASER, BILATERAL OVARIAN DRILLING, AND DECOMPRESSION OF LEFT OVARIAN CYST PROCEDURE: APPROX 3 MM LONG TIP OF CLEAR GLASS LASER FIBER BROKE OFF WHILE IN USE IN PT. PIECE SEEN IN ABDOMEN AND ATTEMPTED TO BE REMOVED FROM ABDOMEN WITH GRASPER, BUT WAS LOST WHEN BEING PULLED OUT OF TROCAR. UNABLE TO CONFIRM WHERE PIECE FELL, WAS NOT SEEN FALLING BACK INTO PT'S ABDOMEN. SURGEON AND OPERATING ROOM STAFF SEARCHED FOR PIECE THROUGHOUT ABDOMINAL CAVITY, TROCAR, DRAPES, FLOOR, AREAS IN PROXIMITY TO PT, AND SUCTION CONTAINERS. UNABLE TO LOCATE PIECE OF LASER TIP. X-RAY CALLED TO ROOM, X-RAY OF REMAINING LASER FIBER TAKEN AND IS NOT VISIBLE ON FILM, THEREFORE PT WAS NOT EXPOSED TO ADD'L RADIATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622610 X-FIBRE KEYCARD REVOLIX JR WRISTFIB GEX LISA LASER PRODUCTS OHG 507929

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Other