BEUDAMED
    FDA Adverse Event Injury Summary report: N

    H30 HOLMIUM LASER 30 WATT HOLMIUM LASER

    MDR report key: 7459264 · Received April 25, 2018

    Report

    Report Number
    1820334-2018-00975
    Event Type
    Injury
    Date Received
    April 25, 2018
    Date of Event
    April 6, 2018
    Report Date
    October 1, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION CONCLUSION CODE: CAUSE TRACED TO COMPONENT FAILURE (4307). INVESTIGATION: EVALUATION: THE LASER DEVICE WAS NOT RETURNED TO THE MANUFACTURER; HOWEVER, A SERVICE REPORT WAS OBTAINED AS PART OF THE INVESTIGATION FOR THIS COMPLAINT. A REVIEW OF THE INSTRUCTIONS FOR USE, QUALITY CONTROL DATA, SPECIFICATIONS AND TRENDS HAS BEEN PERFORMED. THE HL-30B IS USED TO FRAGMENT STONES, AS WELL AS FOR SOFT TISSUE INCISION, HEMOSTASIS, AND ABLATION IN THE URINARY TRACT. PER THE INSTRUCTIONS FOR USE (IFU) TROUBLESHOOTING SECTION, A "SIMMER FAILURE" IS CAUSED BY THE ¿FLASH LAMP NOT FUNCTIONAL¿ AND THE SOLUTION IS TO ¿CALL FOR SERVICE.¿ THE SERVICE REPORT CONFIRMED THE FLASH LAMP WAS BLACK AND BURNED ON THE ANODE END. THE HIGH VOLTAGE WAS PRESENT AT THE PUMPING CHAMBER AT THE TIME OF STARTUP. THE LAMP WOULD NOT IONIZE. THE LAMP WAS REPLACED AND THE PULSE COUNTER RESET. THE CAPACITORS WERE LOOSE. BUSS BAR AND TERMINALS WERE TIGHTENED. A FEW OF THE HIGH VOLTAGE TERMINALS ON THE MPS WERE ABLE TO BE TIGHTENED BY A QUARTER OF A TURN. AFTER SERVICE WAS COMPLETED THE LAMP SIMMERS AND FIRES. A SEARCH OF COMPLAINT RECORDS ON THIS LASER DEVICE WITH SERIAL NUMBER: (B)(4) SHOWED THERE HAVE BEEN NO COMPLAINTS RECEIVED ON THIS DEVICE PRIOR TO THIS REPORTED ISSUE. PREVIOUS TO THIS COMPLAINT THE CUSTOMER DID NOT HAVE A SERVICE CONTRACT WITH THE MANUFACTURER. SINCE THIS COMPLAINT WAS REPORTED, THERE HAVE BEEN AN ADDITIONAL FOUR COMPLAINTS RECEIVED FROM THE CUSTOMER. 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). 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 THAT A SIMMER FAILURE WAS RECEIVED ON A H30 HOLMIUM LASER 30 WATT AND THE USER ABORTED THE UROLOGY PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT OUTCOME IS UNKNOWN AS INFORMATION WAS NOT PROVIDED BY THE REPORTER.

    Description of Event or Problem · 1

    THE CASE WAS ALREADY IN PROGRESS WITH THE PATIENT UNDER GENERAL ANESTHESIA WHEN THE NURSE TURNED THE RHAPSODY LASER ON AND GOT THE "SIMMER ERROR". BIOMED HAD THE BACKUP LASER APART UP IN THEIR SHOP AWAITING A PART. THE CASE WAS ABORTED. THE PATIENT CAME BACK THE FOLLOWING WEEK WHEN THE BACKUP LASER WAS WORKING AND IT WAS USED TO COMPLETE THE PROCEDURE. THERE ARE NO KNOWN FURTHER COMPLICATIONS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304293 H30 HOLMIUM LASER 30 WATT HOLMIUM LASER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other