BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK® SINGLE-USE HOLMIUM LASER FIBER

    MDR report key: 6828883 · Received August 29, 2017

    Report

    Report Number
    1820334-2017-02778
    Event Type
    Malfunction
    Date Received
    August 29, 2017
    Date of Event
    August 23, 2017
    Report Date
    January 29, 2018
    Manufacturer
    COOK INC
    Product Code
    GEX
    UDI-DI
    00827002252950
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM: A MEDWATCH REPORT WAS RECEIVED FROM THE FACILITY ON 02OCT2017, (B)(4). THE MEDWATCH STATED, "WHILE OPENING FOR A CASE A PIECE OF BACK (BLACK PER PICTURE PROVIDED) DEBRIS WAS NOTED ON THE INSIDE OF AN UNOPENED STERILE PACKER OF LASER FIBER."; INVESTIGATION SUMMARY: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. ONE UNOPENED COMPLAINT DEVICE WAS RETURNED FOR INVESTIGATION. THERE WERE NO VISIBLE ANOMALIES OBSERVED WITH THE PRODUCT OR PACKAGING MATERIAL. VISUAL EXAMINATION OF THE PACKAGE WAS PERFORMED. FREE FLOATING BLACK DEBRIS THAT MEASURED 2MM IN WIDTH WAS VISUALIZED INSIDE THE SEALED PACKAGE. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE HAS BEEN ATTRIBUTED TO A MANUFACTURING ISSUE. 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). PMA/510(K): 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

    THE AREA REPRESENTATIVE REPORTED THAT THE CUSTOMER CALLED TO REPORT THERE IS SOMETHING INSIDE OF THE SEALED PACKAGE CONTAINING A COOK® SINGLE-USE HOLMIUM LASER FIBER. THIS DEVICE REMAINS UNOPENED AND UNUSED. THERE WAS NO PATIENT CONTACT AND NO CONSEQUENCES OR IMPACT TO A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607773 COOK® SINGLE-USE HOLMIUM LASER FIBER GEX LASER INSTRUMENT, SURGICAL GEX COOK INC 00827002252950

    Patients

    Seq Age Sex Outcome Treatment
    1