BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1188HD CCU

    MDR report key: 1386945 · Received May 14, 2009

    Report

    Report Number
    2936485-2009-00043
    Event Type
    Injury
    Date Received
    May 14, 2009
    Date of Event
    April 15, 2009
    Report Date
    April 15, 2009
    Manufacturer
    STRYKER ENDOSCOPY SAN JOSE
    Product Code
    FXM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE PROVIDED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE IMAGE WENT COMPLETELY GREEN. EFFORTS TO TROUBLESHOOT THE FAULT BY TELEPHONE, FAILED TO RESOLVE THE PROBLEM. ALLEGEDLY, THE OPERATION WOULD BE CONVERTED TO AN OPEN PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1188HD CCU CAMERA CONTROL CONSOLE FXM STRYKER ENDOSCOPY SAN JOSE 08F024914

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other