BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 7631174 · Received June 22, 2018

    Report

    Report Number
    1820334-2018-01688
    Event Type
    Malfunction
    Date Received
    June 22, 2018
    Date of Event
    May 30, 2018
    Report Date
    June 27, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABILITY DECISION REASSESSED. THE COMPLAINT HAS BEEN DEEMED AS NON-REPORTABLE.

    Description of Event or Problem · 0

    THE REPORTABILITY DECISION HAS BEEN REASSESSED. BASED ON THE INFORMATION RECEIVED ON 26JUNE2018 ADVISING THE PROCEDURE WAS COMPLETED AS "A NORMAL ONE", THIS COMPLAINT HAS BEEN DEEMED NOT REPORTABLE AS THERE IS NO INFORMATION INDICATING THERE WAS AN ADVERSE EVENT. THE REPORTED PRODUCT MALFUNCTION HAS NOT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT NOR IS IT LIKELY TO CAUSE OR CONTRIBUTE TO A SERIOUS INJURY. THE NON-FUNCTIONAL LASER FIBER WOULD BE REPLACED AND THE PROCEDURE COMPLETED WITHOUT ADVERSE CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K124030. 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 DURING A URETEROSCOPY PROCEDURE, THE COOK® SINGLE-USE HOLMIUM LASER FIBER CEASED TO FUNCTION AFTER 5 MINUTES OF USE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.  ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471690 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 8484529 00827002252936

    Patients

    Seq Age Sex Outcome Treatment
    1