BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLIMLINE 200

    MDR report key: 846625 · Received June 16, 2006

    Report

    Report Number
    2914019-2006-00051
    Event Type
    Other
    Date Received
    June 16, 2006
    Date of Event
    April 10, 2006
    Report Date
    June 16, 2006
    Manufacturer
    LUMENIS
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER CUSTOMER DID NOT RETURN THE FIBER TO LUMENIS FOR EVAL. ROOT CAUSE: AT THE TIME OF THIS REPORT, THE FIBER WAS NOT AVAILABLE FOR ANALYSIS AND NO FURTHER CONCLUSIONS CAN BE DRAWN. POSSIBLE DEVICE PROBLEM PENDING FURTHER INVESTIGATION. IF ENDUSER PROVIDES ADDITIONAL INFORMATION, LUMENIS WILL FILE A FOLLOW-UP MDR. CORRECTED DATA: THE USER FACILITY REPORTED THE PRODUCT WAS "MICROVASIVE SLIMLINE 200"; THE CORRECT PRODUCT NAME IS "SLIMLINE 200" (SLIMLINE 200 MICRON FIBER). THE USE FACILITY MEDWATCH MISREPORTED THE DEVICE MFR AS BOSTON SCIENTIFIC CORP.; THE CORRECT DEVICE MFR IS LUMENIS.

    Description of Event or Problem · 1

    THE SURGEON WAS USING THE DEVICE TO BREAK UP A RIGHT URETERAL STONE. A SMALL BLUE FRAGMENT ON THE LASER FIBER BROKE OFF IN THE RIGHT URETER. THE SURGEON WAS NOT ABLE TO RETRIEVE THE FRAGMENT. SURGEON STATED THE FRAGMENT SHOULD WASH OUT WHEN THE BLADDER EMPTIES. ENDUSER FILED USER FACILITY MEDWATCH REPORT NUMBER 1401850000-2006-8016 IN RESPONSE TO THE INCIDENT. THE USER FACILITY REPORTED THE PRODUCT WAS "MICROVASIVE SLIMLINE 200"; THE CORRECT PRODUCT NAME IS "SLIMLINE 200" (SLIMLINE 200 MICRON FIBER). THE USER FACILITY MEDWATCH MISREPORTED THE DEVICE MFR AS BOSTON SCIENTIFIC CORP.; THE CORRECT DEVICE MFR IS LUMENIS. LUMENIS WILL PROVIDED CORRECTED DATA IN ITS MEDWATCH REPORT. ENDUSER REPORTED IN ITS MEDWATCH REPORT THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. BSC CONTACTED THE ENDUSER ON 05/31/06 AND 06/14/06 WITH QUERIES; AS OF 06/16/06 THE ENDUSER HAS NOT REPLIED TO THE QUERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE 200 HOYAG/NDYAG SURGICAL LASER FIBER GEX LUMENIS 0626-221-20 38860306

    Patients

    Seq Age Sex Outcome Treatment
    1 * NOT KNOWN PER THE ENDUSER MEDWATCH