BEUDAMED
    FDA Adverse Event Other Summary report: N

    DUO TORNE SIDELITE 550

    MDR report key: 851357 · Received May 8, 2007

    Report

    Report Number
    2914019-2005-00072
    Event Type
    Other
    Date Received
    May 8, 2007
    Date of Event
    June 16, 2005
    Report Date
    May 8, 2007
    Manufacturer
    LUMENIS LTD.
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE DEVICE DISTRIBUTOR, THE SURGICAL FIBER WAS DESTROYED BY THE END USER AND WOULD NOT BE RETURNED FOR ANALYSIS. WITHOUT DEVICE EVALUATION, NO CONCLUSION COULD BE DRAWN REGARDING ROOT CAUSE. THE FIBER WAS REPLACED BY LUMENIS. IT IS POSSIBLE FOR THE STAINLESS STEEL TIP OF THE DUOTOME 550 FIBER TO DETACH FROM THE FIBER DURING USE. THE DIRECTIONS FOR USE INSTRUCT THE END USER TO LOCATE THE DETACHED TIP AND REMOVE IT USING FORCEPS, IRRIGATING THE AREA WELL TO REMOVE ANY DEBRIS. 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

    CUSTOMER REPORTED THAT CAP BURST OFF THE FIBER DURING A HOLAP PROCEDURE. THE PHYSICIAN USED A SECOND FIBER. THE PHYSICIAN COMPLETED THE CASE WITH A ROLLER BALL AS PT WAS BLEEDING. PT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUO TORNE SIDELITE 550 FIBERS GEX LUMENIS LTD. NA 29890405

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention NONE REPORTED