BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NON-STERILE FIBER INSERT FOR NASAL PROBES

    MDR report key: 1638995 · Received March 23, 2010

    Report

    Report Number
    2914019-2010-00013
    Event Type
    Injury
    Date Received
    March 23, 2010
    Date of Event
    February 22, 2010
    Report Date
    March 23, 2010
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    PMA / PMN Number
    K082809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE ROOT CAUSE TO BE 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 THAT ONE PATIENT SUSTAINED A SEPTAL PERFORATION AND A SECOND PATIENT SUSTAINED AN ALAR SCAR AFTER NASAL LASER TURBINECTOMIES USING A NASAL FIBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE PATIENT SUSTAINED A SEPTAL PERFORATION AND A SECOND PATIENT SUSTAINED AN ALAR SCAR AFTER NASAL LASER TURBINECTOMIES USING A NASAL FIBER.

    Additional Manufacturer Narrative · 2

    AN EVALUATION OF THE EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE ROOT CAUSE TO BE BURYING OF THE NASAL FIBER IN TISSUE WHILE ABLATING, CAUSING DEBRIS BUILD UP AT THE FIBER TIP IN CONTRADICTION TO DEVICE LABELING.

    Additional Manufacturer Narrative · 2

    AN EVALUATION OF THE EVENT DETAILS BY A LUMENIS MEDICAL SUBJECT MATTER EXPERT CONCLUDED THE ROOT CAUSE TO BE 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 · 2

    IT WAS REPORTED THAT ONE PATIENT SUSTAINED A SEPTAL PERFORATION AND A SECOND PATIENT SUSTAINED AN ALAR SCAR AFTER NASAL LASER TURBINECTOMIES USING A NASAL FIBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-STERILE FIBER INSERT FOR NASAL PROBES CARBON DIOXIDE SURGICAL LASER FIBER DELIVERY DEVICE GEX LUMENIS LTD. AA2757200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR
    2 52 YR