BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 8620665 · Received May 17, 2019

    Report

    Report Number
    1820334-2019-01157
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 17, 2019
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002235533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: HL-30C, RHAPSODY H-30 HOLMIUM LASER SYSTEM, S/N (B)(4). (B)(6). OCCUPATION: PURCHASER. PMA/510(K) #: K163197. INVESTIGATION ¿ EVALUATION: A VISUAL INSPECTION AND FUNCTIONAL TESTING OF THE RETURNED DEVICE WAS PERFORMED. A DOCUMENT BASED INVESTIGATION WAS ALSO CONDUCTED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND TRENDS. VISUAL EXAMINATION CONFIRMED TWO FIBERS WERE RECEIVED INSIDE ONE PACKAGE. BOTH FIBERS WERE INSIDE THE PROTECTIVE COIL AND SECURED INSIDE A PACKAGING TRAY. THE SECOND FIBER WAS RETURNED BECAUSE IT DID NOT WORK. VISUAL EXAMINATION OBSERVED THE CLADDING HAS A MELTED APPEARANCE WITH BLACK CHARRING ON THE DISTAL TIP. THE FIBER OPTICS IS BROKEN AND RECEDED INSIDE THE CLADDING. THE FIBER WAS TESTED ON AN IN-HOUSE DEMO LASER MACHINE. THE FIBER REGISTERED CHIP SERIAL NUMBER (B)(4) AS EXPIRED USED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A SEARCH OF COMPLAINT HISTORY RECORDS REVEALED ONE OTHER COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. THE SECOND COMPLAINT IS FROM THE SAME CUSTOMER FOR A DIFFERENT FAILURE AND OCCURRED DURING THE SAME PROCEDURE. THE INSTRUCTIONS FOR USE (IFU) ADVISES THAT A NUMBER OF DIFFERENT FACTORS AFFECT THE LIFE OF ANY PARTICULAR FIBER, INCLUDING: EXTENDED LASING POWER. CONTINUOUS LASING WITH FIBER TIP IN CONTACT WITH TISSUE. LASING WITH A CONTAMINATED OR DAMAGED PROXIMAL END. IMPROPER HANDLING. POOR LASER BEAM ALIGNMENT OR FOCUS. NEVER SUBJECT FIBER OPTICS TO SHARP BENDS IN HANDLING, USE OR STORAGE. ALWAYS KEEP CONNECTOR END DRY AND FREE FROM CONTAMINATES. DISCARD ANY FIBEROPTIC ASSEMBLY THAT IS CRACKED OR BROKEN, OR DOES NOT MEET MINIMUM TRANSMISSION STANDARDS. DO NOT EXCEED POWER LIMITS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. THE DEVICE IS INSPECTED VISUALLY AND FUNCTIONALLY FOR CRACKS AND FRACTURES BY MANUFACTURING AND QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. ANALYSIS OF THE RETURNED FIBER FOUND THAT THE FIBER TIP WAS BROKEN AND PULLED OFF. CHARRING AND A MELTED APPEARANCE WERE ALSO OBSERVED INDICATING LASER ENERGY WAS PUT THROUGH THE FIBER AFTER THE FIBER WAS DAMAGED. BASED ON THESE OBSERVATIONS, THE REPORT OF TIP BENT AND DAMAGE TO THE CHANNEL OF THE URS IS LIKELY BUT NOT DIRECTLY CONFIRMED. ANY OF FACTORS PROVIDED IN THE IFU CAN CAUSE FIBER BREAKAGE. AN INVESTIGATION CONCLUSION CANNOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THE FIBER HAS A BENT TIP. THE NURSE EXPLAINED THAT THEY REALIZED THAT THE TIP WAS BENT DURING USE AND THE FIBER DAMAGED THE CHANNEL OF THE URETEROSCOPE (URS). THEY WERE USING AN H30 LASER BOX. THE PROCEDURE TO TREAT THE KIDNEY STONES WAS COMPLETED USING A NEW FIBER. AS REPORTED, NO ONE REALIZED OR NOTICED AN ERROR MESSAGE WHILE THE FIBER WAS IN USE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. DURING THE DEVICE FAILURE ANALYSIS PERFORMED BY THE MANUFACTURER ON 02MAY2019, IT WAS DISCOVERED THE RETURNED FIBER WAS BROKEN AND CHARRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413243 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC G23553 8928989 00827002235533

    Patients

    Seq Age Sex Outcome Treatment
    1