BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOBEAM¿ HOLMIUM LASER FIBER

    MDR report key: 7247304 · Received February 7, 2018

    Report

    Report Number
    1018233-2018-00379
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 19, 2018
    Report Date
    March 20, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    GEX
    UDI-DI
    00801741122194
    PMA / PMN Number
    K120926
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED 1 OPEN AND 2 UNOPENED LASER FIBER. THE REPORTED EVENT WAS CONFIRMED AS USE-RELATED. PER EVALUATION OF THE RETURNED SAMPLES, COMPLETED BY LASER PERIPHERALS LLC, SHOWED BOTH THE PROXIMAL CONNECTOR ENDS AND DISTAL ENDS IN GOOD CONDITION FOR ALL THREE LASER FIBER SAMPLES RETURNED. FOR THE UNOPENED PACKAGES, THERE WERE NO VISIBLE DEFECTS, AND WHEN ATTACHED TO AN IN-HOUSE LUMENIS LASER, BOTH FIBERS EXHIBITED IDEAL LASER SPOT SIZE AND SHAPE. FOR THE OPENED LASER FIBER, REFERENCED IN THE EVENT DESCRIPTION, A COMPOUND FRACTURE BREAK WAS VISIBLE 14" FROM THE DISTAL END. LASER PERIPHERALS STATES THAT COMPOUND FRACTURES ARE GENERALLY CAUSED BY EXCESSIVE BENDING AND STRESS, POSSIBLE MISHANDLING OF FIBER IN THE SURGICAL FIELD, OR THROUGH INSTRUMENTATION INTERACTIONS. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: ¿BARD ENDOBEAM HOLMIUM LASER FIBERS 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 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 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). DEVICE STORAGE: STORE AT ROOM TEMPERATURE. DO NOT EXPOSE TO ORGANIC SOLVENTS, IONIZING RADIATION, OR ULTRAVIOLET LIGHT. ROTATE INVENTORY SO THAT DEVICES ARE USED PRIOR TO EXPIRATION DATE ON THE PACKAGE LABEL. INSTRUCTIONS FOR USE: NOTE: IN ORDER TO ENSURE LASER ENERGY IS EFFECTIVELY DELIVERED THROUGH THE LASER FIBERS, LASER GENERATORS MUST BE CALIBRATED AND ALIGNED ACCORDING TO THE SMALLEST FIBER BEING UTILIZED. THIS IS ESPECIALLY IMPORTANT WHEN UTILIZING SMALL GAUGE FIBERS (=200¿). IMPROPER CALIBRATION AND/OR IMPROPER ALIGNMENT MAY RESULT IN A WEAK AIMING BEAM AND/OR DIMINISHED POWER OUTPUT. NOTE: REFRAIN FROM STARTING THE PROCEDURE UNTIL A FIBER IS PROPERLY CONNECTED AND ALIGNED, AND LASER LIGHT IS BEING PROPERLY TRANSMITTED. NOTE: IT IS GOOD PRACTICE TO ENSURE THAT SPARE FIBERS ARE AVAILABLE IN THE OPERATING ROOM IN CASE OF A FIBER FAILURE DURING THE CLINICAL PROCEDURE. 1. REFER TO THE LASER SYSTEM MANUAL FOR USE, INDICATIONS AND INSTRUCTIONS. 2. IF REQUIRED FOR PROPER SYSTEM FUNCTION AND OPERATION, THE LASER SYSTEM MAY BE CALIBRATED FOR USE WITH THE HOLMIUM LASER FIBER. PLEASE REFER TO YOUR LASER USER MANUAL FOR CALIBRATION REQUIREMENTS AND PARAMETERS. 3. READ ALL FIBER LABELING COMPLETELY. REMOVE THE FIBER CAREFULLY FROM ITS PACKAGE, AVOIDING ANY INADVERTENT CONTAMINATION OR DAMAGE. VISUALLY INSPECT THE FIBER BEFORE USE. IF ANY DAMAGE IS OBSERVED SUCH AS BREAKS, KINKS OR DAMAGED COMPONENTS, DO NOT USE THE FIBER, RETAIN THE DEVICE FOR MANUFACTURER NOTIFICATION AND USE A REPLACEMENT FIBER. 4. REMOVE THE PROTECTIVE CAP (DO NOT HOLD THE RUBBER STRAIN RELIEF OR THE FIBER) AND ATTACH THE CONNECTOR TO THE LASER SYSTEM LAUNCH PORT. MAKE SURE THE CONNECTOR IS FULLY ENGAGED ACCORDING TO THE SYSTEM¿S USER MANUAL AND CONTROL PANEL INDICATORS. THE CONNECTOR ONLY NEEDS TO BE HAND TIGHTENED: DO NOT OVER TIGHTEN. CAUTION: CARE MUST BE TAKEN TO KEEP THE CONNECTOR CLEAN. DO NOT TOUCH THE EXPOSED FIBER SURFACE. 5. TURN THE LASER ON. OPERATE THE SYSTEM¿S CONTROLS IN ACCORDANCE WITH THE USER MANUAL AND AT SETTINGS APPROPRIATE TO THE PROCEDURE. 6. PLACE THE HOLMIUM LASER FIBER AT THE DESIRED POSITION TO THE TREATMENT SITE. POSITION THE ENTIRE FIBER LENGTH CAREFULLY TO AVOID INADVERTENT DAMAGE OR CONTAMINATION. CONFIRM THAT THE AIMING BEAM IS VISIBLE. 7. DEPRESS THE LASER SYSTEM¿S FOOTSWITCH TO ACTIVATE THE LASER OUTPUT. CAUTION: DO NOT PINCH OR OTHERWISE EXCESSIVELY BEND THE FIBER WHEN LASING. FIBER FAILURE MAY OCCUR. 8. KEEP THE DISTAL TIP OF THE FIBER AS CLEAN AS POSSIBLE DURING USE TO PREVENT OVERHEATING AND DAMAGE. IF REMOVAL IS NECESSARY TO CLEAN ACCUMULATED DEBRIS, CAREFULLY WIPE ALONG THE FIBER LENGTH WITH A SOFT GAUZE AND HYDROGEN PEROXIDE. CAUTION: DO NOT SCRUB OR USE ABRASIVE MATERIALS. 9. FOLLOWING THE LASER PROCEDURE, SHUT THE LASER SYSTEM OFF, AS DESCRIBED IN YOUR USER MANUAL, AND REMOVE THE FIBER ASSEMBLY FROM THE LASER. IMMEDIATELY REPLACE THE PROTECTIVE CAP OVER THE CONNECTOR END OF THE FIBER ASSEMBLY.¿ 1069: "L" 2199: "NL".

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPROPER LASING OCCURRED ON THE PRODUCT; THE LASER FROM THE FIBER COULD NOT BE STOPPED BEFORE USAGE. PER ADDITIONAL INFORMATION THE LASER WAS BROKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IMPROPER LASING OCCURRED ON THE PRODUCT; THE LASER FROM THE FIBER COULD NOT BE STOPPED BEFORE USAGE. PER ADDITIONAL INFORMATION THE LASER WAS BROKEN.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPROPER LASING OCCURRED ON THE PRODUCT; THE LASER FROM THE FIBER COULD NOT BE STOPPED BEFORE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93353 ENDOBEAM¿ HOLMIUM LASER FIBER ENDOBEAM GEX C.R. BARD, INC. (COVINGTON) -1018233 BMBPLP06 00801741122194

    Patients

    Seq Age Sex Outcome Treatment
    1