BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIM LINE SIS 365

    MDR report key: 3312795 · Received August 28, 2013

    Report

    Report Number
    3004135191-2013-00054
    Event Type
    Injury
    Date Received
    August 28, 2013
    Date of Event
    April 30, 2013
    Report Date
    August 8, 2013
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K990947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIBER WAS RETURNED TO LUMENIS FOR EXAMINATION. A VISUAL INSPECTION OF THE RETURNED SUBJECT DEVICE BY LUMENIS TECHNICAL SPECIALIST CONCLUDED THE 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: FIBER BROKEN DUE TO EXCESSIVE BENDING OR EXCEEDING THE FIBER TENSILE STRENGTH IN CONTRADICTION TO IFU. 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 (B)(4)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 BY A PHYSICIAN AT A FACILITY IN THE (B)(6) THAT THE DURING A PROCEDURE IN WHICH A LUMENIS SLIMLINE 365 SIS REUSABLE FIBER WAS DEPLOYED WHILE THE PHYSICIAN WAS "HOLDING THE FIBRE IN A BIG LOOP" THE FIBER BROKE IN HALF BURNING THE PHYSICIAN'S HAND AND GRAZING ANOTHER STAFF MEMBER AS WELL. THE PHYSICIAN REPORTED THE INCIDENT TO (B)(6) WHO FORWARDED THE EVENT REPORT TO LUMENIS FOR INVESTIGATION. NO PATIENT HARM WAS REPORTED BY THE PHYSICIAN. NO INFORMATION REGARDING A REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424209 SLIM LINE SIS 365 LASER FIBER DELIVERY DEVICE ACCESSORY GEX LUMENIS, LTD. SIS 365 83130113

    Patients

    Seq Age Sex Outcome Treatment
    1 Other