BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 6770485 · Received August 7, 2017

    Report

    Report Number
    1820334-2017-02292
    Event Type
    Malfunction
    Date Received
    August 7, 2017
    Report Date
    November 7, 2017
    Manufacturer
    COOK INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE HOLMIUM LASER FIBER WAS NOT RETURNED FOR ANALYSIS. PHOTOGRAPHS WERE NOT PROVIDED. WITHOUT THE ACTUAL DEVICE, A PHYSICAL EXAMINATION COULD NOT BE PERFORMED. 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 AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. A REVIEW OF COMPLAINT HISTORY ALSO COULD NOT BE PERFORMED WITHOUT THE DEVICE LOT NUMBER. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION; THE ROOT CAUSE OF THIS REPORTED ISSUE COULD NOT BE DETERMINED AND A CONCLUSION COULD NOT BE DRAWN. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED WHILE USING THE COOK® SINGLE-USE HOLMIUM LASER FIBER FROM THE FIRST LASER SHOT THE FIBER BROKE AT THE DISTAL PART. REQUESTS FOR ADDITIONAL PATIENT INFORMATION AND EVENT DETAILS HAVE BEEN UNANSWERED. AS REPORTED, NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551507 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1