BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTACT LASER SCALPEL

    MDR report key: 6302 · Received August 16, 1993

    Report

    Report Number
    6302
    Event Type
    Injury
    Date Received
    August 16, 1993
    Date of Event
    July 1, 1993
    Report Date
    July 21, 1993
    Manufacturer
    HGM MEDICAL LASER SYSTEMS INC.
    Product Code
    LQJ
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    CONTACT LASERS SCALPEL (LOT #35292F300A-12) SET @ 8 WATTS AND FIRED INSIDE NOSE ON NASAL POLYPS. A BLUE-GREEN LIGHT WAS VISIBLE AT THE TIP WHEN THE LASER WAS FIRED. PHYSICIAN HAD FIRED THE LASER SEVERAL TIMES AT WHICH TIME THE FIBER FAILED. PATIENT SUSTAINED A 6X4MM SECOND DEGREE BURN ON THE RIGHT NASAL SILL. INSPECTION OF THE FIBER SHOWED THAT THE METAL SHEATH HAD BEEN BLACKENED FROM THE BEND DISTAL FOR 7MM. THE DEGREE OF CHARRING WAS WORSE ON THE CONCAVE (UNDERSIDE) HALFDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: VISUAL EXAMINATION. RESULTS OF EVALUATION: TELEMETRY FAILURE. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INSERVICED BY OTHER FACILITY STAFF. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTACT LASER SCALPEL N/A LQJ HGM MEDICAL LASER SYSTEMS INC. N/A 35292F300A-12

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention