BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ODYSSEY LASER 30 WATT GENERATOR

    MDR report key: 7929680 · Received October 3, 2018

    Report

    Report Number
    1820334-2018-02876
    Event Type
    Injury
    Date Received
    October 3, 2018
    Date of Event
    September 14, 2018
    Report Date
    November 7, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    PMA / PMN Number
    K080525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. INVESTIGATION EVALUATION: THE LASER GENERATOR WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CUSTOMER USED A THIRD PARTY TO SERVICE THE LASER UNIT AND NO SERVICE REPORT HAS BEEN PROVIDED FOR REVIEW. A REVIEW OF COMPLAINT HISTORY, INSTRUCTIONS FOR USE, AND TRENDS HAS BEEN PERFORMED. A SEARCH OF COMPLAINT RECORDS ON THIS LASER GENERATOR WITH SERIAL NUMBER (B)(4), SHOWED THERE HAVE BEEN 3 PREVIOUS COMPLAINTS RECEIVED ON THIS DEVICE PRIOR TO THIS REPORTED ISSUE. THE PREVIOUS COMPLAINTS ARE UNRELATED TO THIS REPORTED ISSUE. THIS PRODUCT CAME TO COOK INC. FROM A SUPPLIER AND QUALITY CONTROLS WERE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. THE INSTRUCTIONS FOR USE (IFU) INCLUDES DIRECTIONS FOR PROPER ELECTRICAL SUPPLY AND PROPER OPERATING CONDITIONS FOR THE DEVICE. PER THE (IFU), TROUBLESHOOTING ERROR CODES: THERE IS NO INFORMATION AVAILABLE WITH REFERENCE TO THE STORAGE OR OPERATIONAL ENVIRONMENT OF THIS GENERATOR OR THE POWER SUPPLIED TO THE UNIT. THERE IS NO INFORMATION AVAILABLE REGARDING THE DEVICE MAINTENANCE AND REPAIR HISTORY. BASED ON THE PROVIDED INFORMATION AN INVESTIGATION CONCLUSION CANNOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. 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

    (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 AN UNKNOWN UROLOGY PROCEDURE, THE ODYSSEY LASER 30 WATT GENERATOR CONTINUOUSLY OVERHEATED AND SHUTDOWN. GETTING AN ERROR 35 - MAIN POWER SUPPLY OVER TEMPERATURE. THE STONE WAS NOT REMOVED AND AN ADDITIONAL SURGERY WILL BE REQUIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772297 ODYSSEY LASER 30 WATT GENERATOR GEX LASER INSTRUMENT, SURGICAL GEX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other