BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLT FIBER DELIVERY SYSTEM & CONTACT TIP

    MDR report key: 159455 · Received March 25, 1998

    Report

    Report Number
    2523356-1998-00001
    Event Type
    Injury
    Date Received
    March 25, 1998
    Report Date
    March 23, 1998
    Manufacturer
    SURGICAL LASER TECHNOLOGIES, INC.
    Product Code
    GEX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT BRONCHOSCOPIC NDIYAG LASER ABLATION USING A CONTACT PROBE AT A POWER OF 25 WATTS WITH AN UNK COOLANT RATE. SURGERY WAS PERFORMED TO REMOVE OR DEBULK AN ENDOBRACHIAL LESION WHICH NEARLY COMPLETELY OBSTRUCTED THE LEFT MAINSTEM BRONCHUS. LESION WAS SQUAMOUS CELL CARCINOMA. PT DEVELOPED BRADYCARDIA WHICH DETERIORATED INTO PULSELESS VTACH. RESUSCITATION WAS SUCCESSFUL. POST OP HEMODYNAMICS AND ECG WERE STABLE, BUT PT REMAINED COMATOSE WITH RIGHT SIDED SEIZURE ACTIVITY. AFTER TWO WEEKS HER NEUROLOGICAL STATUS IMPROVED ALTHOUGH LEFT HEMIPLEGIA PERSISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLT FIBER DELIVERY SYSTEM & CONTACT TIP NDIYAG LASER FIBER & CONTACT PROBE GEX SURGICAL LASER TECHNOLOGIES, INC. FEF SMALL FIBER,SMTR 1.5 PROBE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening