BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOBEAM, HOLMIUM LASER FIBER

    MDR report key: 2926634 · Received January 17, 2013

    Report

    Report Number
    1018233-2013-00122
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 20, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES: "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 UTEROSCOPIC 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 CLIPPING AND CLEAVING" AND "FIBER OUTPUT TEST" SECTIONS OF THIS IFU. DO NOT EXCEED THE RECOMMENDED POWER LEVELS WHEN UTILIZING THE BARD ENDOBEAM HOLMIUM LASER FIBER. CHECK THE DEVICE FOR COMPLETENESS ONCE REMOVED FROM THE PT." "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 TIP OF THE FIBER BROKE OFF WHEN THE SURGEON INSERTED INTO THE SCOPE. PER ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012, THE TIP WAS BROKEN AT THE POINT OF ENTRY INTO THE SCOPE WHEN TRYING TO FIT THROUGH THE SURE SEAL DEVICE AT THE PORT OF THE SCOPE. THERE WAS NO IMPACT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25748 ENDOBEAM, HOLMIUM LASER FIBER GEX LASER PERIPHERALS LLC NA BMWHG008

    Patients

    Seq Age Sex Outcome Treatment
    1