BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMLINE 550 FIBER

    MDR report key: 3796918 · Received May 7, 2014

    Report

    Report Number
    3004135191-2014-00030
    Event Type
    Injury
    Date Received
    May 7, 2014
    Date of Event
    March 29, 2014
    Report Date
    May 7, 2014
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K990947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS INVESTIGATED THE EVENT REPORT CONTACTING THE INITIAL REPORTER TO OBTAIN INVESTIGATION INFORMATION WHICH WAS PROVIDED. THE FIBER WAS RETURNED TO LUMENIS FOR EXAMINATION. A VISUAL INSPECTION OF THE RETURNED SUBJECT DEVICE BY LUMENIS TECHNICAL SPECIALIST CONCLUDED THE PROBABLE ROOT CAUSE FOR THE REPORTED EVENT TO BE IMPROPER HANDLING OF THE FIBER WITHOUT PATIENT CONTACT EITHER DURING THE CLINICAL PROCEDURE OR UNPACKING/PREPARATION IN CONTRADICTION TO THE DFU. A REVIEW OF PRODUCT LABELING CONFIRMED THAT LABELING DID NOT CONTRIBUTE TO THE REPORTED. A REVIEW OF THE RISK ANALYSIS FOUND EVENT RECURRENCE TO BE EXTREMELY REMOTE AND WITHIN STATISTICAL LIMITS WITH LOW POTENTIAL FOR COMPLICATIONS TO THE PATIENT. LUMENIS RISK ANALYSIS CONSIDER ABOUT 10 CASES OF SUCH BURNS OF FIBER PER YEAR; THE REPORTED EVENT IS WITHIN ACCEPTABLE STATISTICAL LIMITS OF RISK ANALYSIS. LUMENIS CONFIRMED WITH THE LOCAL DISTRIBUTOR THAT CUSTOMERS PURCHASING SUBJECT DEVICE FIBER ARE TRAINED TO REFRAIN FROM BENDING THE FIBER DURING USE. ADDITIONALLY, THE DISTRIBUTOR STATED THAT END USERS ARE ADVISED TO NOT HANDLE THE DEVICE DURING DEPLOYMENT OF LASER ENERGY.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A FOREIGN VIGILANCE REPORT THAT DURING A PROCEDURE PERFORMED WITH A LUMENIS SLIMLINE 550 REUSABLE LASER FIBER DELIVERY DEVICE THE FIBER SNAPPED DURING USE RESULTING IN A SMALL BURN TO SURGEON'S LEFT PALM. THE INITIAL REPORTER STATED THE BREAK OCCURRED ON THE TENTH (10TH) USE OF THE SUBJECT DEVICE. THE INITIAL REPORTER STATED NO MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE PERMANENT IMPAIRMENT. THE BURN IS REPORTED TO HAVE HEALED WITH NO PERMANENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276248 SLIMLINE 550 FIBER LASER FIBER DELIVERY DEVICE ACCESSORY GEX LUMENIS, LTD. SLIMLINE 550 8325/12/08

    Patients

    Seq Age Sex Outcome Treatment
    1 Other