BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL FIBER

    MDR report key: 1030176 · Received April 8, 2008

    Report

    Report Number
    2914019-2008-00019
    Event Type
    Injury
    Date Received
    April 8, 2008
    Date of Event
    March 18, 2008
    Report Date
    April 11, 2008
    Manufacturer
    LUMENIS, LTD. YOKNEAM
    Product Code
    GEX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIBER WAS RETURNED. VISUAL EVALUATION FOUND THE FIBER WAS BROKEN DUE TO MISUSE BY EXCEEDING THE BEND RADIUS OF FIBER OR EXCEEDING THE TENSILE STRENGTH. LUMENIS HAS REQUESTED INFORMATION REGARDING PATIENT OUTCOME. SHOULD ADDITIONAL EVENT INFORMATION BE PROVIDED AS REQUESTED, A FOLLOWUP MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TRANSURETHRAL URETERO-LITHOTOMY (TUL) PROCEDURE THE TIP OF A SLIMLINE FIBER WAS BROKEN AND A 5-8 MM FIBER FRAGMENT REMAINED INSIDE THE PATIENT. THE PHYSICIAN WAS UNABLE TO FIND THE DETACHED FRAGMENT AND THE PROCEDURE WAS CLOSED WITH PLACEMENT OF URETERAL STENT IN ORDER TO PASS THE FRAGMENT. IT WAS REPORTED THE FIBER WAS DAMAGED BY EXCESS FORCE AT THE SCOPE CHANNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL FIBER LASER FIBER DELIVERY DEVICE GEX LUMENIS, LTD. YOKNEAM 840, 840 SLIMLINE200 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention