BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPATH SUBCU-DISSECTOR

    MDR report key: 62136 · Received January 14, 1997

    Report

    Report Number
    1218017-1997-00059
    Event Type
    Injury
    Date Received
    January 14, 1997
    Date of Event
    December 16, 1996
    Report Date
    January 14, 1997
    Manufacturer
    LACEY MANUFACTURING CO.
    Product Code
    GDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING A CORONARY ARTERY BYPASS WITH VEIN HARVESTING, ANOTHER CO'S SCOPE STUCK IN THE SVSD1 AND SVSR1. THE PHYSICIAN'S ASSISTANT WAS UNABLE TO COMPLETE THE PROCEDURE EASILY. 12/30/96 THE CASE WAS CONVERTED TO OPEN WHEN THE CAMERA BROKE. CJE 12/31/96 REP REPORTS THE DHL KIT WAS NOT PICKED UP THEREFORE, THE PRODUCT WILL NOT BR RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH SUBCU-DISSECTOR SUBCU-DISSECTOR GDI LACEY MANUFACTURING CO. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention