BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NASAL PROBE FPA 14635 STR. ENT PROBEW/ R.H. MIRROR

    MDR report key: 2143285 · Received June 28, 2011

    Report

    Report Number
    3004135191-2011-00030
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    April 8, 2011
    Report Date
    June 28, 2011
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K030033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AN ON-SITE EXAMINATION OF THE SUBJECT DEVICE BY A LUMENIS TECHNICAL SUBJECT MATTER EXPERT FOUND THE SYSTEM TO BE FUNCTIONING TO MANUFACTURER'S SPECIFICATIONS. NO RELATED DEVICE MALFUNCTION WAS REPORTED OR OBSERVED DURING THE EXAMINATION. REASONABLE ATTEMPTS WERE MADE TO OBTAIN PATIENT INFORMATION INCLUDING GENDER AND AGE, HOWEVER SPECIFIC DETAILS WERE NOT PROVIDED. AFTER AN INTERVIEW WITH THE ATTENDING PHYSICIAN, OBSERVATION OF TREATMENTS, AND REVIEW OF PROCEDURES BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT, THE EXPERT CONCLUDED THE ROOT CAUSE OF THE REPORTED EVENTS TO BE IMPROPER TECHNIQUE EMPLOYED BY THE DEVICE OPERATOR: BURYING OF THE NASAL FIBER IN TISSUE WHILE ABLATING CAUSING DEBRIS BUILD UP AT THE FIBER TIP IN CONTRADICTION TO DEVICE LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A DISTRIBUTOR IN (B)(6) THAT PATIENTS SUSTAINED NASAL SCARRING FOLLOWING NASAL LASER TURBINECTOMIES USING LUMENIS NASAL PROBES. IT WAS FURTHER REPORTED THE PATIENTS REQUIRED FOLLOW-UP SURGERY. LUMENIS CONFIRMED FOUR (4) REPORTED INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NASAL PROBE FPA 14635 STR. ENT PROBEW/ R.H. MIRROR CARBON DIOXIDE SURGICAL FIBER DELIVERY DEVICE GEX LUMENIS, LTD. 14635 843010333

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention