BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPSIS Z-CAM

    MDR report key: 35041 · Received August 7, 1996

    Report

    Report Number
    MW1009658
    Event Type
    Injury
    Date Received
    August 7, 1996
    Date of Event
    July 11, 1996
    Report Date
    July 29, 1996
    Manufacturer
    V. MUELLER DIV. BAXTHER HEALTHCARE CORP.
    Product Code
    FWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    SURGEONS COMPLAINED THE CAMERA WAS BLURRY AND OUT OF FOCUS, AND UNABLE TO SEE ANATOMY. LAPAROSCOPIC CHOLECYSTECTOMY CONVERTED TO OPEN PROCEDURE. BIOMEDICAL ENGINEERING TECH EVALUATION OF CAMERA SYSTEM FOUND THAT THE CAMERA PICTURE HAS TOO MUCH CHROMA (PURPLE). DURING THE PAST YEAR THE CAMERA HAS "HSD" PROBLEMS WITH COLOR CHANGING AND AN INABILITY TO MAINTAIN COLOR DURING SURGERY CASES. THE CAMERA HAS ALSO BEEN FLUCTUATING IN LIGHT INTENSITY, WHICH HAS MADE IT DIFFICULT TO DISTINGUISH THE COLOR OF TISSUE. THE HOSP OWNS 2 CAMERA SYSTEMS AND BOTH HAVE A HISTORY OF POOR QUALITY PICTURE. BOTH HAVE BEEN RETURNED TO THE MFR TWICE DURING THE PAST YEAR FOR VARIOUS PROBLEMS, THE MFR HAS NOT FOUND ANY PROBLEM WITH THE COLOR FLUCTUATIONS WITH THE CAMERAS. THE MONITORS HAVE ALSO BEEN RETURNED TO THE MFR FOR EVALUATION OF COLOR CHANGES. REPLACED A DIODE IN EACH TO IMPROVE THE PICTURE CONTRAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPSIS Z-CAM SURGICAL CAMERA BOX FWC V. MUELLER DIV. BAXTHER HEALTHCARE CORP. VS7100 *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention