BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIM LINE EZ SURGICAL FIBER

    MDR report key: 2883243 · Received December 21, 2012

    Report

    Report Number
    3004135191-2012-00067
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 21, 2012
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K011703
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW BY A LUMENIS TECHNICAL SPECIALIST OF LABELING FOR THE SD WAS COMPLETED AND NO DEVIATION FROM SPECIFICATIONS WAS NOTED. THE DHR (AND/OR EQUIVALENT TEST DATA) WAS REVIEWED AND NO DEVIATION FROM THE DESIGN SPECIFICATION WAS OBSERVED. REASONABLE ATTEMPTS WERE MADE TO OBTAIN THE SUBJECT DEVICE FROM THE USER FACILITY HOWEVER, THE DEVICE WAS NOT RETURNED FOR EVALUATION. THEREFORE, NO PHYSICAL EVALUATION OF THE SUBJECT DEVICE COULD BE PERFORMED. AN EVALUATION OF THE REPORTED EVENT BY A LUMENIS TECHNICAL SPECIALIST DETERMINED THE PROBABLE ROOT CAUSE TO BE EXCESSIVE BENDING FORCES APPLIED UNDER POWER IN CONTRADICTION TO INSTRUCTIONS IN PRODUCT LABELING. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN SUSTAINED A SMALL PINHEAD-SIZE BURN TO THE MIDDLE FINGER WHILE PERFORMING A PROCEDURE USING A LUMENIS SLIMLINE EZ FIBER. IT WAS FURTHER REPORTED BY THE PHYSICIAN THAT THE LASER FIBER BROKE IN HALF OUTSIDE OF THE PATIENT. NO PATIENT HARM OCCURRED. MEDICAL INTERVENTION WAS REPORTEDLY NOT REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIM LINE EZ SURGICAL FIBER LASER FIBER DELIVERY DEVICE ACCESSORY GEX LUMENIS, LTD. EZ 200 0063690312

    Patients

    Seq Age Sex Outcome Treatment
    1 60 Other