BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 6597999 · Received May 30, 2017

    Report

    Report Number
    1820334-2017-01303
    Event Type
    Malfunction
    Date Received
    May 30, 2017
    Date of Event
    September 14, 2016
    Report Date
    November 7, 2017
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002235533
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) - K124030. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: THE HOLMIUM LASER FIBER WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED. PHOTOGRAPHS WERE ALSO NOT PROVIDED. WITHOUT THE ACTUAL DEVICE, AN ANALYSIS COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE USER FACILITY ADVISING THE LASER FIBER WAS USED WITH A RHAPSODY HL-30 USING ENERGY/PULSE SETTING 0.5J, REPETITION RATE 20 HZ AND TOTAL ENERGY OF 1360. 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 REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. A REVIEW OF COMPLAINT HISTORY FOUND NO OTHER COMPLAINTS ASSOCIATED WITH COMPLAINT DEVICE LOT NUMBER 6487641. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION; THE ROOT CAUSE OF THIS REPORTED ISSUE COULD NOT BE DETERMINED AND NO CONCLUSION COULD BE DRAWN. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN INTENDED URETEROSCOPY AND A LASER LITHOTRIPSY WITH STENT EXCHANGE PROCEDURE ON A PATIENT BY USING COOK® SINGLE-USE HOLMIUM LASER FIBER. DURING THE PROCEDURE, THE PHYSICIAN DISCOVERED THAT THE LASER FIBER WAS BROKEN. THE LASER WENT THROUGH THE PHYSICIAN'S GOWN AS WELL AS THE STERILE DRAPE. THE PHYSICIAN AND PATIENT WERE NOT BURNED FROM THE DEVICE MALFUNCTIONING. ALSO, THERE WAS NO OTHER REPORTED INJURY TO THE PATIENT OR THE PHYSICIAN. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER LASER FIBER. NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379345 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC N/A 00827002235533

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR