BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    C8301, S ALEXIS WND PROT/RET 5/BX

    MDR report key: 7010586 · Received November 8, 2017

    Report

    Report Number
    2027111-2017-02104
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Date of Event
    October 5, 2017
    Report Date
    November 8, 2017
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    KGW
    UDI-DI
    00607915117207
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT UNIT WAS NOT RETURNED TO APPLIED MEDICAL FOR EVALUATION. IN THE ABSENCE OF THE SUBJECT DEVICE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE EVENT. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS, AS NECESSARY, TO ENSURE THE PERFORMANCE AND SAFETY OF ITS PRODUCTS.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED - VIDEO ASSISTED THORACIC SURGERY - LOBECTOMY "REMOVING FROM PATIENT ALEXIS RIPPED IN HALF NO HARM TO PATIENT." ADDITIONAL INFORMATION RECEIVED VIA EMAIL AT OCTOBER 10, 2017 FROM MATERIAL MANAGEMENT AT (B)(6) HOSPITAL. THE DEVICE IS NOT AVAILABLE FOR RETURN AS THE DEVICE IS WITH RISK MANAGEMENT DEPARTMENT AND WILL BE SECURED AT THE HOSPITAL. THE LOCATION OF THE RIP IS IN THE CENTER OF THE SHEATH. " THE RINGS ARE INTACT". ALL MATERIAL WAS RETRIEVED. PATIENT STATUS - "NO HARM TO PATIENT." TYPE OF INTERVENTION - NA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790378 C8301, S ALEXIS WND PROT/RET 5/BX KGW KGW APPLIED MEDICAL RESOURCES C8301 1300056 00607915117207

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR