BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMLINE 550

    MDR report key: 3481425 · Received August 15, 2013

    Report

    Report Number
    3004135191-2013-00057
    Event Type
    Injury
    Date Received
    August 15, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 9, 2013
    Manufacturer
    LUMENIS, LTD.
    Product Code
    GEX
    PMA / PMN Number
    K990947
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE FIBER IS REPORTEDLY EN-ROUTE TO LUMENIS' MANUFACTURING FACILITY IN ISRAEL FOR EXAMINATION AND ROOT CAUSE DETERMINATION. A PRELIMINARY EVALUATION OF THE REPORTED EVENT 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: 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 FACILITY IN THE (B)(6) THAT A SCRUB NURSE SUSTAINED A BURN TO THE HAND WHILE HOLDING A LUMENIS SLIMLINE 550 FIBER AS THE FIBER BROKE IN HALF OUTSIDE THE PATIENT. THE INITIAL REPORTER STATED THE FIBER APPEARED TO HAVE BEEN BENT IN HALF AS THE BREAK POINT. NO PATIENT HARM OCCURRED. 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
    395545 SLIMLINE 550 LASER FIBER DELIVERY DEVICE ACCESSORY GEX LUMENIS, LTD. SLIMLINE 550

    Patients

    Seq Age Sex Outcome Treatment
    1 Other