BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LASER SCALPEL

    MDR report key: 31199 · Received December 29, 1995

    Report

    Report Number
    31199
    Event Type
    Malfunction
    Date Received
    December 29, 1995
    Date of Event
    May 18, 1995
    Report Date
    December 29, 1995
    Manufacturer
    SURGICAL LASER TECHNOLOGIES, INC.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    DEVICE BEING USED TO EXCISE UTERINE TISSUE. WHEN LASER FIBER WITHDRAWN FROM ABDOMEN VIA SUCTION PORT WITH SCALPEL ATTACHED, IT WAS PLACED ON THE ABDOMEN. ON REPLACING THE FIBER DOWN THE SUCTION PORT THE SCALPEL WAS NOT VISIBLE. THE SURGEON USED THE LAPAROSCOPY CAMERA TO SEARCH THE ABDOMINAL AREA BUT THE PROBE WAS NOT FOUND. IT IS BELIEVED THAT THE SCALPEL MAY HAVE BECOME LOOSE AND FALLEN OFF THE LASER FIBER POSSIBLY BECAUSE IT HAD NOT BEEN TIGHTENED SUFFICIENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LASER SCALPEL LASER SCALPEL GEX SURGICAL LASER TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other