BEUDAMED
    FDA Adverse Event Other Summary report: N

    SLIMLINE 365

    MDR report key: 974386 · Received March 15, 2007

    Report

    Report Number
    2914019-2005-00064
    Event Type
    Other
    Date Received
    March 15, 2007
    Date of Event
    December 27, 2004
    Report Date
    March 15, 2007
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    LUMENIS REQUESTED THAT THE CUSTOMER RETURN THE FIBER TO LUMENIS VIA THE DEVICE DISTRIBUTOR FOR EVAL. THE FIBER WAS NOT RECEIVED, DESPITE MULTIPLE REQUESTS FROM LUMENIS, AND NO FURTHER INVESTIGATION WAS POSSIBLE. BASED ON THE AVAILABLE INFO, NO CONCLUSION COULD BE DRAWN REGARDING ROOT CAUSE. IN THE ORIGINAL ANALYSIS, THIS INCIDENT WAS DETERMINED BY LUMENIS NOT TO BE MDR REPORTABLE. THIS INCIDENT WAS LATER RECLASSIFIED BY LUMENIS AS MDR REPORTABLE AS A RESULT OF AN INTERNAL AUDIT AND THE FDA LETTER.

    Description of Event or Problem · 1

    USER FACILITY FILED AN MDR REPORT REGARDING AN INCIDENT IN WHICH A SLIMLINE 365 FIBER BROKE IN THE PROXIMAL ASPECT OF THE URETEROSCOPE DURING A LEFT URETEROSCOPY WITH LASER LITHOTRIPSY. THIS CAUSED A HOLE TO BURN IN THE URETEROSCOPE. PER THE ENDUSER, THE SCOPE AND FIBER WERE REMOVED COMPLETELY INTACT AND THERE WERE NO PT INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLINE 365 FIBERS GEX LUMENIS LTD. * 011402

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other OTHER THERAPIES NOT KNOWN PER USER FACILITY MDR