BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 6676306 · Received June 29, 2017

    Report

    Report Number
    1820334-2017-01536
    Event Type
    Injury
    Date Received
    June 29, 2017
    Date of Event
    June 2, 2017
    Report Date
    November 16, 2017
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252943
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (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.

    Additional Manufacturer Narrative · 1

    510(K) = K124030. INVESTIGATION ¿ EVALUATION : A REVIEW OF COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. THE OPEN HOLMIUM LASER FIBER PACKAGE (LABELED RPN HLF-S273-HSMA, LOT 7601045) WAS RECEIVED. THE FIBER WAS RETURNED IN TWO SEGMENTS. THE DISTAL SEGMENT LENGTH IS 80.5CM. DAMAGE TO THE BLUE CLADDING ON THE DISTAL SEGMENT WAS OBSERVED. CLADDING WAS WRINKLED AND PUSHED TOGETHER IN AN ACCORDION FASHION IN THREE AREAS. THE DISTAL TIP OF CLADDING HAS BEEN STRIPPED LEAVING A SMALL FIBER EXTENDING FROM THE CLADDING. THE POINT OF SEPARATION ON THIS SEGMENT HAD A BLACKENED CHARRED APPEARANCE. THE CLADDING WAS WRINKLED AND SCRAPED IN SEVERAL AREAS. THE SMALLER PORTION OF THE FIBER WAS EXPOSED FROM THE CLADDING AT THE POINT OF SEPARATION. THE TOTAL LENGTH OF THE RETURNED FIBER WAS FOUND WITHIN SPECIFICATIONS. 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 THIS COMPLAINT DEVICE LOT NUMBER. THE IFU DOES CONTAIN INFORMATION REGARDING THE FAILURE MODE. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED OR REPORTED AT THIS TIME. IT IS LIKELY RELATED TO THE USE OF THE PRODUCT AND THE WAY IT WAS HANDLED. IT IS FEASIBLE TO SUGGEST THAT THE FIBER DAMAGE COULD HAVE BEEN CAUSED BY THE SCOPE USED DURING THE PROCEDURE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS PERFORMING AN INTENDED LEFT URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE ON A PATIENT BY USING COOK® SINGLE-USE HOLMIUM LASER FIBER. IT WAS REPORTED THAT THE FIBER BROKE IN HALF INSIDE OF THE SCOPE WHEN THE PHYSICIAN WAS TRYING TO PULL THE FIBER OUT OF THE SCOPE. THE PROXIMAL END OF THE FIBER REMAINED IN BOTH THE SCOPE AND THE PATIENT'S URETHRA. THE PHYSICIAN PULLED OUT THE BROKEN PIECE OF FIBER OUT OF PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457161 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC N/A 00827002252943

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention