BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7384842 · Received March 30, 2018

    Report

    Report Number
    1820334-2018-00948
    Event Type
    Malfunction
    Date Received
    March 30, 2018
    Date of Event
    March 26, 2018
    Report Date
    May 11, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252967
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND TRENDS WAS CONDUCTED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE FRACTURING OF THE LASER FIBER. A REVIEW OF COMPLAINT HISTORY REVEALED THIS TO BE THE ONLY COMPLAINT ASSOCIATED WITH LOT NUMBER 7754382. 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; DEVICE INTEGRITY PRIOR TO SHIPPING. THIS DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU). AS FOUND IN THE PRECAUTIONS SECTION: 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. WITH THE INFORMATION AVAILABLE THE DEFINITIVE CAUSE OF THE DAMAGED FIBER IS UNDETERMINABLE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: 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 THE COOK® SINGLE-USE HOLMIUM LASER FIBER BROKE INSIDE THE SCOPE. AN ALTERNATIVE FIBER WAS OPENED AND USED TO COMPLETE THE PROCEDURE AS INTENDED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229033 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 00827002252967

    Patients

    Seq Age Sex Outcome Treatment
    1