BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 6423862 · Received March 22, 2017

    Report

    Report Number
    1820334-2017-00494
    Event Type
    Malfunction
    Date Received
    March 22, 2017
    Date of Event
    February 22, 2017
    Report Date
    April 17, 2017
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252943
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K124030. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SEND UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. 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. ONE USED LASER FIBER WAS RETURNED FOR THE INVESTIGATION. THE POINT OF SEPARATION WAS ON THE DISTAL TIP. THE CLADDING APPEARED TO BE TWISTED ON THE END AND DISPLAYED CHARRING. BLUE CLADDING APPEARED TO BE STRETCHED AND PULLED TO SEPARATION. THE OPTICAL FIBER ON THE DISTAL TIP WAS FRACTURED INSIDE THE CLADDING. THE FRACTURED PIECE OF THE DEVICE WAS NOT RETURNED FOR THE INVESTIGATION. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A UROLOGY PROCEDURE. THE COOK® SINGLE-USE HOLMIUM LASER FIBER WAS THE DEVICE IN USE. THE INITIAL REPORTER INDICATED THAT THE TIP BROKE OFF DURING THE PROCEDURE. AS A RESULT OF THIS EVENT, THE REPORTER WAS NOT AWARE OF ANY UNINTENDED SECTIONS OF THE DEVICE REMAINING INSIDE OF THE PATIENT¿S BODY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206913 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC N/A 00827002252943

    Patients

    Seq Age Sex Outcome Treatment
    1