BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7889216 · Received September 19, 2018

    Report

    Report Number
    1820334-2018-02710
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 14, 2018
    Report Date
    October 11, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002235526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCTS. (B)(4). INVESTIGATION: EVALUATION. A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED. THIS INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, SPECIFICATIONS, AND TRENDS. ONE OPENED PACKAGE LABELED RPN HLF-S365-H30 WITH LABEL LOT NUMBER 8628926 WAS RECEIVED. THE DEVICE WAS RECEIVED INSIDE THE PROTECTIVE COIL AND RETURNED WITHOUT THE PACKAGING TRAY. UPON RECEIPT, IT WAS NOTED THE PROXIMAL END OF THE DEVICE WAS PROTRUDING FROM THE COIL. DIMENSIONAL VERIFICATION CONFIRMED LENGTH OF THE RETURNED DEVICE MEASURED 300.1CM. VISUAL EXAMINATION OF THE RETURNED DEVICE WAS PERFORMED. THE FIBER OPTICS IS PROTRUDING 6MM FROM THE BLUE POLYMER CLADDING ON THE DISTAL TIP. DURING MICROSCOPIC MAGNIFICATION, CLEAR INNER LINING IS OBSERVED EXTENDING BEYOND THE BLUE CLADDING. THERE IS 2MM OF FIBER OPTICS EXTENDING ABOVE THE LINING. WHEN EXAMINED THE LINING WAS PULLED AWAY FROM THE FIBER OPTIC USING TWEEZERS. DURING THE EXAMINATION OF THE FIBER TIP, THE OPTICS BROKE 3MM BELOW THE DISTAL TIP OF THE CLADDING. FURTHER EXAMINATION REVEALED THE DISTAL EDGE HAS BEEN CHIPPED. NO ADDITIONAL DAMAGE OR MANUFACTURING ANOMALIES WERE NOTED ON THE DEVICE. THIS DEVICE IS TESTED TO ASSURE THE PROGRAM HAS RECOGNIZED THE FIBER AND NO FAILURE CODES ARE PRESENT. IN ADDITION, IT IS INSPECTED TO ASSURE NO BREAKS ARE PRESENT ALONG THE FIBER LENGTH AND THE GREEN OUTPUT FROM THE END OF FIBER CREATES A WELL-DEFINED CIRCLE. 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. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE NO NON-CONFORMANCES THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A SEARCH OF COMPLAINT RECORDS REVEALED THIS IS THE ONLY COMPLAINT ASSOCIATED WITH COMPLAINT LOT NUMBER 8628926. 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. THE COMPLAINT IS CONFIRMED BASED ON THE DEVICE ANALYSIS. FROM THE PROVIDED INFORMATION, AN INVESTIGATION CONCLUSION IS NOT ABLE TO BE ESTABLISHED, HOWEVER, IT IS LIKELY THAT DAMAGE OCCURRED DURING HANDLING. THE COMPLAINT IS CONFIRMED BASED ON THE DEVICE ANALYSIS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. 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 · 0

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510K #: K124030. 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, THEY WERE GETTING READY TO DO LASER LITHOTRIPSY, THE COOK® SINGLE-USE HOLMIUM LASER FIBER WAS INSERTED INTO THE SCOPE AND THEY NOTICED THE TIP OF THE FIBER WAS CRACKED. THE CRACKED FIBER DID NOT MAKE PATIENT CONTACT. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730773 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 8628926 00827002235526

    Patients

    Seq Age Sex Outcome Treatment
    1