BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOBEAM SINGLE-USE HOLMIUM LASER FIBERS

    MDR report key: 2875985 · Received December 13, 2012

    Report

    Report Number
    1018233-2012-02101
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Report Date
    November 19, 2012
    Manufacturer
    LASER PERIPHERALS LLC
    Product Code
    GEX
    PMA / PMN Number
    K120926
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT COULD NOT BE CONFIRMED. NO SAMPLE WAS RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN. BASED ON THE INVESTIGATION FINDINGS, CURRENT MANUFACTURING CONTROLS ARE CONSIDERED ADEQUATE AS TO DETECT AND SEGREGATE ANY NON-CONFORMING UNIT. EVENT DESCRIBED COULD NOT BE CONFIRMED AS A MANUFACTURING RELATED ISSUE. THE INSTRUCTIONS FOR USE, WHICH ACCOMPANIES ALL DEVICES, CURRENTLY ADDRESSES THE POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE PRECAUTIONS: WHEN REMOVING THE FIBER FROM ITS POUCH OR TRAY, SECURE THE DISTAL TIP TO AVOID DAMAGE OR CONTAMINATION. DO NOT APPLY EXCESSIVE FORCE TO THE TIP OF THE FIBER AS BREAKAGE MAY RESULT. BEGIN LASING AT THE LOWEST POSSIBLE POWER/ENERGY SETTING TO ACHIEVE THE DESIRED EFFECT. USE LOWER POWER LEVELS AND SHORTER PULSES TO FAMILIARIZE YOURSELF WITH THE OPERATION OF THE BARD ENDOBEAM HOLMIUM LASER FIBER. HIGH POWER/LONG DURATION OF LASER ENERGY WHILE PLACING THE TIP IN CONTACT WITH TISSUE MAY DAMAGE OR SIGNIFICANTLY REDUCE THE LIFE OF THIS PRODUCT. DIRECT CONTACT BY LASER BEAM MAY CAUSE DAMAGE TO GUIDEWIRES, BASKETS OR OTHER URETEROSCOPIC ACCESSORIES. IF FIBER TIP IS VISIBLY DAMAGED OR REQUIRES EXCESSIVE AMOUNTS OF ENERGY TO AFFECT COAGULATION OR VAPORIZATION, DISCONTINUE USE AND REPLACE WITH A NEW FIBER FOR OPTIMUM RESULTS. IF DESIRED, STRIP AND CLEAVE THE FIBER AS OUTLINED IN THE "INSTRUCTIONS FOR STRIPPING AND CLEAVING" AND "FIBER OUTPUT TEST" SECTIONS OF THE IFU. DO NOT EXCEED THE RECOMMENDED POWER LEVELS WHEN UTILIZING THE BARD ENDOBEAM HOLMIUM LASER FIBER. CHECK THE DEVICE FOR COMPLETENESS ONCE REMOVED FROM PATIENT. ADVERSE EVENTS: THE POTENTIAL ADVERSE EFFECTS ASSOCIATED WITH HOLMIUM LASER FIBERS MAY INCLUDE BUT ARE NOT LIMITED TO: PERFORATION, HEMATOMA, VASOVAGAL RESPONSE, INFECTION, THERMAL DAMAGE, EDEMA, BLEEDING, DISCOMFORT, HYPERTENSION, DELAY IN HEALING, POST-PROCEDURE FEVER AND LEUKOCYTOSIS (ASSOCIATED WITH TISSUE DESTRUCTION). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE BROKE IN HALF DURING THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOBEAM SINGLE-USE HOLMIUM LASER FIBERS GEX LASER PERIPHERALS LLC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1