BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7459470 · Received April 25, 2018

    Report

    Report Number
    1820334-2018-01191
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    April 9, 2018
    Report Date
    May 21, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION, EVALUATION: THE COOK® SINGLE-USE HOLMIUM LASER FIBER WAS NOT RETURNED FOR EVALUATION. NO PHOTOGRAPHS WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, AND TRENDS WAS CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY REVEALED TWO ADDITIONAL COMPLAINTS ASSOCIATED WITH THE LOT NUMBER 8242225 FOR FIBER FRACTURES. ONE OF THE TWO ADDITIONAL COMPLAINTS CAME FROM THE SAME FACILITY AS THIS REPORT. THIS DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU). AS PER THE IFU PRECAUTIONS: A NUMBER OF DIFFERENT FACTORS AFFECT THE LIFE OF ANY PARTICULAR FIBER, INCLUDING: EXTENDING LASING AT HIGH POWER. CONTINUOUS LASING WITH THE FIBER TIP IN CONTACT WITH TISSUE. IMPROPER HANDLING, POOR LASING BEAM ALIGNMENT OF FOCUS, NEVER SUBJECT FIBER OPTICS TO SHARP BENDS IN HANDLING, USE, OR STORAGE. ALWAYS KEEP CONNECTOR-END DRY AND FREE FROM CONTAMINANTS. DISCARD ANY FIBER OPTIC ASSEMBLY THAT IS CRACKED OR BROKEN, OR DOES NOT MEET MINIMUM TRANSMISSION STANDARDS. DO NOT EXCEED RECOMMENDED 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. THE LASER FIBER WAS NOT RETURNED. THE CAUSE OF THE GLASS TIP BREAKING IS UNKNOWN. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT. 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

    PROCEDURE WAS A RIGHT URETEROSCOPY WITH LASER LITHOTRIPSY UTILIZING A LUMENIS 100W VERSA PULSE, SERIAL NUMBER (B)(4) AT SETTINGS 0.8J/30HZ.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: 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 THAT WHILE USING THE COOK® SINGLE-USE HOLMIUM LASER FIBER (USING THE ¿POPCORN¿ METHOD) TO LASER THE STONES IN THE KIDNEY, THE GLASS TIP BROKE OFF AT THE BLUE CLADDING. THE PROCEDURE WAS FINISHED BY PLACING A STENT. THE GLASS TIP WAS NEVER REMOVED FROM THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304074 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 00827002252936

    Patients

    Seq Age Sex Outcome Treatment
    1 LUMENIS 100W VERSA PULSE, SERIAL NUMBER (B)(4)