BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 8428713 · Received March 18, 2019

    Report

    Report Number
    1820334-2019-00653
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Report Date
    May 7, 2019
    Manufacturer
    COOK INC
    Product Code
    GEX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. THIS REPORT IS BEING SUBMITTED TO REPORT CORRECTED INFORMATION. THERE WAS NO ALLEGED MALFUNCTION WITH THIS DEVICE. CLARIFIED INFORMATION CONFIRMED THAT THIS DEVICE WAS USED TO COMPLETE THE PROCEDURE. (B)(6). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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

    CORRECTED INFORMATION: THREE FIBERS WERE USED IN THE CASE. (REFERENCE MDR # 1820334-2019-00651, AND MDR # 1820334-2019-00652). THE THIRD FIBER (THE SUBJECT OF THIS REPORT) WAS USED TO FINISH THE PROCEDURE. THERE WAS NO DAMAGE TO THIS FIBER REPORTED. THERE WAS NO ALLEGATION OF A DEFICIENCY WITH THIS DEVICE. THERE WAS NO INJURY TO THE PATIENT OR STAFF.

    Additional Manufacturer Narrative · 1

    PMA/510K # K163197. (B)(4). 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 IS REPORTED DURING A URETEROSCOPY WITH LASER LITHOTRIPSY USING AN UNSPECIFIED URETEROSCOPE AND A COOK® SINGLE-USE HOLMIUM LASER FIBER, THE FIBER MALFUNCTIONED DURING THE CASE AND THE TIP ERODED MUCH QUICKER THAN NORMAL. A SECOND (ASSOCIATED PR# (B)(4)) AND THIRD FIBER (ASSOCIATED PR# (B)(4)) WERE OPENED DURING THE CASE. IT IS REPORTED THAT THESE FIBERS MALFUNCTIONED AND ERODED AS WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE THREE FIBERS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS FROM THIS ALLEGED PRODUCT COMPLAINT. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222222 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 URETEROSCOPE