BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 8412198 · Received March 12, 2019

    Report

    Report Number
    1820334-2019-00646
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    March 1, 2019
    Report Date
    March 12, 2019
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002235533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION/EVALUATION: A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, SPECIFICATIONS AND TRENDS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS THE REPORTED COMPLAINT DEVICE LOT NUMBER. VISUAL EXAMINATION CONFIRMED THE FIBER IS BROKEN 12.5CM FROM THE DISTAL TIP. THE BROKEN SEGMENT IS HELD TOGETHER BY THE BLUE CLADDING. UNDER MAGNIFICATION THERE WAS NO CHARRING AND A CLEAN BREAK OF THE FIBER OPTICS. LENGTH OF FIBER MEASURES WITHIN THE SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT. A REVIEW OF COMPLAINT HISTORY SHOWS THIS IS THE ONLY COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. 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. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. WITH THE PROVIDED INFORMATION, AN INVESTIGATION CONCLUSION CANNOT BE DETERMINED. APPROPRIATE QUALITY CONTROL IS IN PLACE TO INSPECT FOR ANY FIBER BREAKAGE DURING THE MANUFACTURING PROCESS. ANY OF THE AFOREMENTIONED FACTORS LISTED IN THE IFU CAN CONTRIBUTE TO LASER FIBER BREAKAGE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THERE IS NO NEW EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # - K163197. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THE COOK® SINGLE-USE HOLMIUM LASER FIBER WAS OPENED TO BE LOADED INTO MACHINE FOR USE. THE FIBRE WAS ALREADY BROKEN TOWARDS THE TIP END. A NEW LASER FIBER WAS OPENED AND USED, IN PLACE OF THE BROKEN FIBER. THERE WAS NO IMPACT ON THE PATIENT OR THE PROCEDURE OUTCOME IN THIS INSTANCE AS THE BROKEN FIBER WAS NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205321 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC G23553 8926416 00827002235533

    Patients

    Seq Age Sex Outcome Treatment
    1