BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7141378 · Received December 21, 2017

    Report

    Report Number
    1820334-2017-04432
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Report Date
    March 27, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).: 510K # - K124030. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND NO PHOTOGRAPHS WERE PROVIDED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A DOCUMENTATION BASED INVESTIGATION WAS PERFORMED. THIS INCLUDED A REVIEW OF THE INSTRUCTIONS FOR USE AND SPECIFICATIONS. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED FOR NON-CONFORMANCES AS THE DEVICE LOT NUMBER WAS NOT PROVIDED. A REVIEW OF COMPLAINT HISTORY COULD NOT BE PERFORMED FOR THE DEVICE/LOT NUMBER COMBINATION AS THE DEVICE LOT INFORMATION WAS NOT PROVIDED. 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. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT IDENTIFY ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. EACH DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU), LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS. 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. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A UROLOGY PROCEDURE THE LASER FIBER BROKE OUTSIDE OF THE SCOPE, CLOSER TO THE LASER DEVICE, WHILE LASER ENERGY WAS BEING DELIVERED. ADDITIONAL QUESTIONS WERE ASKED REGARDING THIS EVENT AND THE LASER FIBER. AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE. THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PATIENT OR STAFF FROM THIS EVENT. IT WAS REPORTED THAT THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919538 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1