BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 9779158 · Received March 3, 2020

    Report

    Report Number
    1820334-2020-00528
    Event Type
    Malfunction
    Date Received
    March 3, 2020
    Date of Event
    February 25, 2020
    Report Date
    April 2, 2020
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: IT WAS REPORTED, DURING A URETEROSCOPY, USING A COOK SINGLE-USE HOLMIUM LASER FIBER, WHEN THE SURGEON PRESSED THE FOOT PEDDLE OF THE LASER MACHINE, THERE WAS A CRACKLING SOUND HEARD WHERE THE FIBER IS CONNECTED TO THE LASER MACHINE. THERE WAS A GREEN FLASH OF LIGHT AND SMOKE AND THE LASER FIBER HAD BURNT OFF AND DETACHED FROM THE FIBER CONNECTOR. A SECOND SAME TYPE FIBER FROM A DIFFERENT LOT NUMBER WAS USED TO LASER THE STONE WITH NO PROBLEMS. A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND SPECIFICATIONS. ONE DEVICE WAS RETURNED FOR INVESTIGATION. VISUAL EXAMINATION CONFIRMED FIBER WAS RETURNED IN USED CONDITION WITH OUT THE PLUG. THE FIBER WAS SEPARATED INTO TWO SEGMENTS. THE FIBER WAS RETURNED PARTIALLY INSIDE THE WHITE PROTECTIVE SHEATH. THE LENGTH OF THE PROTECTIVE SHEATH WAS 144.3CM. PROXIMAL END OF THE SHEATH WAS COVERED WITH BLACK CHARRED DEBRIS INSIDE AND OUTSIDE THE SHEATH, MATERIAL AT POINT OF SEPARATION HAD A MELTED APPEARANCE. LENGTH OF FIBER WAS 290.5CM WITH 6MM OF FIBER OPTIC EXTENDING FROM THE DISTAL TIP OF THE BLUE JACKET. POINT OF SEPARATION WAS COVERED WITH BLACK CHARRED DEBRIS, MATERIAL AT POINT OF SEPARATION HAS A MELTED APPEARANCE. FIBER OPTIC WAS VISIBLE AT THE END OF THE BLUE JACKET AND IS BROKEN AND CHIPPED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: EXTENDED LASING AT HIGH POWER, CONTINUOUS LASING WITH THE FIBER TIP IN CONTACT WITH TISSUE POOR REPROCESSING, LASING WITH A CONTAMINATED OR DAMAGE PROXIMAL END, IMPROPER HANDLING, POOR LASING BEAM ALIGNMENT OR FOCUS, ALWAYS KEEP CONNECTOR END DRY AND FREE OF CONTAMINANTS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. COOK HAS CONCLUDED THAT BASED ON EVIDENCE PRESENTED, POTENTIAL CAUSE OF FIBER BREAKAGE CAN BE RELATED TO IMPROPER HANDLING OF LASER FIBER AND ANY OF THE PRECAUTIONS LISTED IN THE IFU COULD CONTRIBUTE TO THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK MEDICAL WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE 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

    NO PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: FLEXIBLE, DISPOSABLE URETEROSCOPE, RHAPSODY H-30 HOLMIUM LASER SYSTEM. INITIAL REPORTER: POSTAL CODE: (B)(6). PMA/510K # - K133788. 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, DURING A URETEROSCOPY, USING A COOK SINGLE-USE HOLMIUM LASER FIBER, WHEN THE SURGEON PRESSED THE FOOT PEDDLE OF THE LASER MACHINE, THERE WAS A CRACKLING SOUND HEARD WHERE THE FIBER IS CONNECTED TO THE LASER MACHINE. THERE WAS A GREEN FLASH OF LIGHT AND SMOKE AND THE LASER FIBER HAD BURNT OFF AND DETACHED FROM THE FIBER CONNECTOR. A SECOND SAME TYPE FIBER FROM A DIFFERENT LOT NUMBER WAS USED TO LASER THE STONE WITH NO PROBLEMS. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242383 COOK SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC G25293 9800680 00827002252936

    Patients

    Seq Age Sex Outcome Treatment
    1