BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7773663 · Received August 10, 2018

    Report

    Report Number
    1820334-2018-02352
    Event Type
    Malfunction
    Date Received
    August 10, 2018
    Date of Event
    July 27, 2018
    Report Date
    September 19, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION CONCLUSION CODE: CAUSE NOT ESTABLISHED (4315). 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 8590152 WAS RECEIVED. THE FIBER AS RETURNED WITHOUT THE PROTECTIVE COIL AND PACKAGING TRAY. EXAMINATION OF THE FIBER CONFIRMED THE FIBER WAS BROKEN 51.3CM FROM THE DISTAL TIP. THE FIBER QUARTZ IS EXPOSED 2.5CM FROM THE DISTAL END OF THE CLADDING. THIS FIBER IS MANUFACTURED WITH 6.5MM OF QUARTZ EXTENDING FROM THE CLADDING. THE LENGTH OF PROXIMAL FIBER SEGMENT MEASURED 248.7CM, TOTAL FIBER LENGTH MEASURED APPROXIMATELY 300CM. AT THE POINT OF SEPARATION CLADDING IS PARTIALLY SEPARATED AND STILL ATTACHED TO BOTH FIBER SEGMENTS. UNDER MAGNIFICATION THE CLADDING HAS A MELTED APPEARANCE AND SHOWS SIGNS OF CHARRING WITH BLACK DISCOLORATION. THIS DEVICE IS TESTED TO ASSURE THE PROGRAM HAS RECOGNIZED THE FIBER AND NO FAILURE CODES ARE PRESENT. IN ADDITION, INSPECTED TO ASSURE NO BREAKS ARE PRESENT ALONG THE FIBER LENGTH AND THE GREEN OUTPUT FROM THE END OF THE FIBER CREATES A WELL-DEFINED CIRCLE. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED THERE WERE NOT ANY 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 85900152. 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. THIS 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 BREAKAGE OF THE FIBER WAS CONFIRMED. DAMAGE TO THE FIBER COULD BE A RESULT OF ANY OF THE FACTORS LISTED ABOVE. A DEFINITIVE CAUSE OF THE BREAK WAS NOT ABLE TO 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. 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 HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    PMA/510K # K124030. (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, DURING A RIGID URETEROSCOPY, ON THE FIRST ATTEMPT TO BE FIRED, THE COOK® SINGLE-USE HOLMIUM LASER FIBER SPLINTERED INSIDE THE PATIENT. USING A REUSABLE METAL GRASPER, THEY WERE ABLE TO GRAB THE LASER FIBER FRAGMENT AND REMOVE IT IN FULL. ALL PIECES WERE REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615321 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 COOK RHAPSODY H30