BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    MDR report key: 6988184 · Received October 30, 2017

    Report

    Report Number
    1820334-2017-03751
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Date of Event
    October 18, 2017
    Report Date
    March 13, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A DOCUMENT BASED INVESTIGATION HAS BEEN PERFORMED WHICH INCLUDED A REVIEW OF THE ONSITE SERVICE REPORT, COMPLAINT HISTORY, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND SPECIFICATIONS. LASER GENERATORS ARE SERVICED IN THE FIELD, NO COMPLAINT DEVICE IS EXPECTED FOR RETURN. NO PHOTOS HAVE BEEN PROVIDED. BASED ON THE FIELD SERVICE REPAIR REPORT DATED 21FEB2018, THE TECH AT THE FACILITY THAT OPERATES THIS DEVICE ADVISED THAT THE LASER UNIT WAS GOING FROM READY MODE TO STANDBY. IT WAS NOT GOING FROM STANDBY TO READY MODE AS IT WAS INITIALLY REPORTED. SERVICE NOTES: ACCORDING TO THE SERVICE AND TROUBLESHOOTING NOTES, THE FAREED CONNECTOR WAS CHECKED TO ENSURE THAT IT WAS PROPERLY SEATED AS WELL AS THE CONNECTIONS TO J3. ALL CONNECTORS WERE PROPERLY SEATED. REPLACED THE FIBER DETECTION RING AND PUT UNIT IN READY MODE FOR APPROXIMATELY 1HR AND COULD NOT DUPLICATE THE REPORTED PROBLEM. TESTED ALL TEST POINTS IN THE FINAL PROCEDURE WITHIN THIS REPORT AT AN AVERAGE OF 150 REPS PER TEST POINT AND THE UNIT STILL DID NOT GIVE ANY ERRORS. NOTE: CUSTOMER STATED THAT LASER HAD THE ISSUE WITH ALL SIZE SINGLE USE FIBERS. THIS DEVICE WAS TESTED WITH 550 SINGLE USE AND 550 MULTI USE FIBERS. A REVIEW OF COMPLAINT HISTORY FOR THIS H30 HOLMIUM LASER 30-WATT HOLMIUM LASER UNIT, S/N (B)(4) REVEALED THIS TO BE THE ONLY COMPLAINT ASSOCIATED WITH THIS REPORTED FAILURE MODE. BASED ON THE AVAILABLE INFORMATION, THE ROOT CAUSE FOR THIS COMPLAINT WAS UNABLE TO BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # IS K130444. (B)(4). 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 THAT THE H30 HOLMIUM LASER 30-WATT HOLMIUM LASER IS GOING FROM STANDBY TO READY MODE ON ITS OWN. AS REPORTED, THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768370 H30 HOLMIUM LASER 30 WATT HOLMIUM LASER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1