BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COHERENT EXCELLASE 55

    MDR report key: 14605 · Received March 15, 1994

    Report

    Report Number
    14605
    Event Type
    Injury
    Date Received
    March 15, 1994
    Date of Event
    February 15, 1994
    Report Date
    March 14, 1994
    Manufacturer
    COHERENT MEDICAL LASER, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    OUTPATIENT LASER LAPAROSCOPY ON 2/15/94. READMITTED AS INPATIENT 2/18/94, WITH ABDOMINAL PAIN. RETURN TO OR FOR REPAIR OF PERFORATED BOWEL, PRESUMABLY FROM LASER. THIS WAS NOT A LASER MALFUNCTION PER THE SURGERY MGR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COHERENT EXCELLASE 55 CO2 LASER GEX COHERENT MEDICAL LASER, INC. XL-55

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention