BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    MDR report key: 7261840 · Received February 9, 2018

    Report

    Report Number
    1820334-2018-00415
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Date of Event
    January 11, 2018
    Report Date
    March 14, 2019
    Manufacturer
    COOK INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: LASER GENERATORS ARE SERVICED IN FIELD, NO COMPLAINT DEVICE IS EXPECTED FOR RETURN. THE INVESTIGATION INCLUDES INFORMATION FROM THE FIELD SERVICE ACTIVITIES PERFORMED AND INCLUDED A REVIEW OF COMPLAINT HISTORY, THE INSTRUCTIONS FOR USE AND DEVICE SPECIFICATIONS. TROUBLESHOOTING WAS PERFORMED BY THE SERVICE TECHNICIAN ON THE H30 HOLMIUM LASER 30 WATT, SERIAL NUMBER (B)(4) AT THE USER FACILITY. THE SERVICE TECHNICIAN REPLACED THERMISTORS. THAT DID NOT RESOLVE THE PROBLEM SO PUT THE ORIGINAL THERMISTORS BACK. TESTED INCOMING VOLTAGES WHICH WERE@ 250V AC. TESTED FUSES AND FOUND F2 AND F4 FUSES WERE BAD. REPLACED FUSES AND TURNED UNIT ON AND IMMEDIATELY HEARD A POP AND SMELLED THE SAME BURNING SMELL. THE SMELL WAS COMING FROM THE POWER SUPPLY BOX. NEW FUSES WERE BLOWN DURING THIS PROCESS. REPEATED THE PROCESS TO CONFIRM WHERE THE SMELL WAS COMING FROM IN FRONT OF THE CUSTOMER. A POWER SUPPLY PROBLEM WAS CONFIRMED. NO ELECTRICAL SAFETY TESTING WAS PERFORMED DUE TO NO POWER COMING INTO THE UNIT. THE POWER SUPPLY WAS REMOVED AND RETURNED TO THE SUPPLIER. THE CUSTOMER DECIDED TO POSTPONE THE REPAIR DUE TO THE COST AND IS DECIDING ON WHETHER TO REPAIR OR PURCHASE ANOTHER LASER. THE DEVICE REMAINS INOPERABLE. A REVIEW OF COMPLAINT HISTORY FOUND ONE OTHER COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE SERIAL NUMBER. THE COMPLAINT WAS FROM THE SAME CUSTOMER. THIS ADDITIONAL COMPLAINT IS UNRELATED TO THE CURRENT COMPLAINT FAILURE MODE. 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 DEFINITIVE ROOT CAUSE FOR THE POWER SUPPLY FAILURE HAS NOT BEEN DETERMINED. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. 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.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # - K130444. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE SUPPLIER INVESTIGATION REPORT WAS RECEIVED. THE SUPPLIER INSPECTED THE POWER SUPPLY/ COMPACT CHARGER WITH SERIAL NUMBER (B)(4) WITH RMA 578-18. CHARGER WAS CONFIRMED TO BE IN WORKING ORDER AND WITHIN SPECIFICATION. SUPPLIER COULD NOT DETERMINE A ROOT CAUSE OF REPORTED EVENT.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THEY HAD A PATIENT ON THE TABLE, THE STAFF PLUGGED THE LASER IN, TURNED IT ON, AND THEY IMMEDIATELY HEARD A "BLOWN SPEAKER NOISE AND BEGAN SMELLING A BURNING ODOR". THEY IMMEDIATELY TURNED THE MACHINE OFF AND CALLED THEIR MATERIALS MANAGER AND "LSO". THE "CES" WAS CALLED TO TRY TO TROUBLESHOOT THE ISSUE. NOTHING WOULD HAPPEN WHEN THE KEY WAS TURNED ON. THE CUSTOMER STENTED THE PATIENT AND ENDED THE CASE.

    Description of Event or Problem · 1

    NO NEW EVENT INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103371 H30 HOLMIUM LASER 30 WATT HOLMIUM LASER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1