BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    MDR report key: 7303174 · Received February 28, 2018

    Report

    Report Number
    1820334-2018-00588
    Event Type
    Injury
    Date Received
    February 28, 2018
    Date of Event
    February 14, 2018
    Report Date
    June 8, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    Report Source
    Manufacturer report
    Reporter Location
    GT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: EVALUATION: LASER GENERATORS ARE SERVICED IN THE FIELD. THE INVESTIGATION INCLUDES A REVIEW OF THE FIELD SERVICE REPORT AND ACTIVITIES, COMPLAINT HISTORY, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA AND TRENDS. TROUBLESHOOTING WAS PERFORMED BY THE SERVICE TECHNICIAN ON THE H30 HOLMIUM LASER 30 WATT, SERIAL NUMBER: (B)(4) AT THE USER FACILITY. A SERVICE REPORT WAS RECEIVED THAT CONFIRMED THE REPORT OF LOW COOLANT FLOW. SERVICING FOUND A LEAK AT ONE OF THE FITTINGS TO THE WATER PUMP WHICH WAS REPLACED. A TEST FOLLOWING SERVICING OBSERVED NO FURTHER ISSUES. A REVIEW OF COMPLAINT HISTORY REVEALED THIS COMPLAINT TO BE THE ONLY COMPLAINT ASSOCIATED TO SERIAL NUMBER: (B)(4). 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. THE CAUSE OF THE CRACKED FITTING WAS UNABLE TO BE DETERMINED. DEVICE REPAIRED AND RETURNED TO SERVICE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K130444. 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 THE H30 HOLMIUM LASER 30-WATT HOLMIUM WAS USED DURING A FLEXIBLEURETEROSCOPY LITHOTRIPSY IN THE KIDNEY OF A (B)(6)-YEAR-OLD FEMALE PATIENT. AS REPORTED, WHEN THE PROCEDURE WAS AT ABOUT 85% PROGRESS (APPROXIMATELY 2 CM STONE), THE H30 HOLMIUM LASER 30-WATT HOLMIUM LASER SHOWED A LOW COOLANT FLOW MESSAGE AND STOPPED WORKING. THE PHYSICIAN DECIDED TO LEAVE A PIGTAIL WHILE THE PROCEDURE IS REPROGRAMMED. ANOTHER LASER LITHOTRIPSY PROCEDURE WILL BE NEEDED. AS REPORTED, THERE WAS A LEAK AT ONE OF THE WATER PUMP HOSE CONNECTORS AND THEY FOUND THE WATER PUMP CONNECTOR FITTING WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146912 H30 HOLMIUM LASER 30 WATT HOLMIUM LASER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R