BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 6910041 · Received October 3, 2017

    Report

    Report Number
    1820334-2017-03420
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    September 21, 2017
    Report Date
    January 25, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: INITIAL REPORTER. INVESTIGATION SUMMARY: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, SPECIFICATIONS, AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICES WERE NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATION COULD BE PERFORMED. NO PHOTOS WERE PROVIDED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE WAS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR EVALUATION, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AREA REPRESENTATIVE THAT WHILE THE COOK® SINGLE-USE HOLMIUM LASER FIBERS WERE IN USE DURING A LASER LITHOTRIPSY PROCEDURE THE FIBERS WERE NOT LASTING VERY LONG AND THEY WERE SHREDDING. THERE WAS NO UNINTENDED SECTION OF THE DEVICE THAT REMAINED INSIDE THE PATIENT¿S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED DUE TO THIS PRODUCT ISSUE. THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT. ADDITIONAL EVENT, PATIENT AND DEVICE INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690683 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 00827002252936

    Patients

    Seq Age Sex Outcome Treatment
    1