BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIV

    MDR report key: 649196 · Received November 26, 2005

    Report

    Report Number
    3005350457-2005-00001
    Event Type
    Injury
    Date Received
    November 26, 2005
    Date of Event
    October 28, 2005
    Report Date
    November 23, 2005
    Manufacturer
    OMNIGUIDE, INC.
    Product Code
    GEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGERY USING THE OMNIGUIDE LASER POWERED SURGICAL INSTRUMENT HAS BEEN PERFORMED AT WOMEN HOSPITAL IN 2005. ON THE SAME DAY THE PHYSICIAN THAT PERFORMED THE SURGERY INFORMED OMNIGUIDE THAT THE PATIENT DEVELOPED THE POST-OPERATIVE COMPLICATIONS. THE FOLLOWING INFORMATION WAS RECEIVED FROM DR. 2005: "PATIENT DEVELOPED A STROKE IMMEDIATELY AFTER TREATMENT WITH THE LASER FIBER FOR CARCINOID OBSTRUCTIVE TO THE BRONCHUS INTERMEDIUS. IN 2005 THE PT DEVELOPED THE STROKE THAT THREATENED HIS LIFE AND PROLONGED HIS HOSPITALIZATION BY ONE WEEK. PATIENT THEN REQUIRED REHAB. HIS SYMPTOMS HAVE NEARLY COMPLETELY RESOLVED. HE ONLY HAS SLIGHT WEAKNESS IN HIS RIGHT LEG BUT CAN AMBULATE WITH A CANE. HE CONTINUES TO GET BETTER AND THE NEUROLOGIST EXPECTS COMPLETE RESOLUTION. THE PATIENT HAD THE PROCEDURE WHICH WAS SUCCESSFUL. HE THEN WOKE UP AND WAS UNABLE TO MOVE HIS LEFT SIDE OR SPEAK COHERENTLY. MULTIPLE MRIS AND CT SHOWED NO BLEEDING AND A LIMITED STROKE. THE CLINICAL DIAGNOSIS WAS AIR EMBOLUS WHICH RESOLVED RAPIDLY. THE PATIENT HAS METASTATIC CARCINOID WITH CARCINOID SYNDROME. HE HAS AIRWAY OBSTRUCTION AND HEMOPTYSIS NOT CONTROLLED WITH YAG LASER OR PDT. THE LASER RESECTION WITH THE DEVICE WAS VERY SUCCESSFUL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMNIGUIDE BEAMPATH CO2 MARK I LASER BEAM DELIV LASER POWERED SURGICAL INSTRUMENT (GEX) GEX OMNIGUIDE, INC. 3-0099-001-00-00 LA030831AG-P1

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R