BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASER FIBER DEFLECTOR

    MDR report key: 19660 · Received February 13, 1995

    Report

    Report Number
    MW1005117
    Event Type
    Injury
    Date Received
    February 13, 1995
    Date of Event
    October 28, 1994
    Report Date
    February 6, 1995
    Manufacturer
    MARLOW SURGICAL TECHNOLOGIES
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING LAPAROSCOPY WITH LASER. SURGEON SAW A SMALL PIECE OF LASER FIBER BREAK OFF INTO PELVIC CAVITY. UNABLE TO RETRIEVE. PROCEDURE CHANGED TO OPEN LAPAROTOMY. UNABLE TO RETRIEVE FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER FIBER DEFLECTOR LASER FIBER DEFLECTOR GEX MARLOW SURGICAL TECHNOLOGIES ML0590

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization