BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3203946 · Received June 26, 2013

    Report

    Report Number
    3203946
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    SONY ELECTRONICS INC., MEDICAL SYSTEMS DIVISION
    Product Code
    LMC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US

    Narratives

    Description of Event or Problem · 1

    DURING THE SURGICAL PROCEDURE, SOME ANATOMICAL PICTURES WERE TAKEN WITH THE LAPAROSCOPIC CAMERA. THE IMAGES ON THE MONITORS WERE CLEAR BUT ONCE THEY WERE PRINTED, THEY APPEARED TO BE EXTREMELY OVER EXPOSED. BIO MEDICAL WAS CALLED MULTIPLE TIMES PRIOR TO THEM ANSWERING THE PAGE. ONCE THEY ANSWERED, THEY CAME TO THE ROOM AND NO RESOLUTION WAS GIVEN TO THE PROBLEM. BIO MEDICAL SAID THAT THEY WOULD HAVE TO COME AT THE END OF THE PROCEDURE TO INSPECT THE PRINTER/CAMERA TOWER. ONCE THE PROCEDURE WAS COMPLETED, BIO MED WAS CALLED ONCE AGAIN AND THEY RETURNED TO THE ROOM. AFTER INSPECTING, NO REASONING WAS PROVIDED AS TO WHAT CAUSED THE IMAGES TO BE CLEAR ON THE MONITOR SCREENS AND TO APPEAR EXTREMELY OVER EXPOSED ON THE PRINTED PICTURES. THE CAPTURED IMAGES WERE NOT ABLE TO BE PRINTED CLEARLY AND THEREFORE, THE SURGEON WAS NOT ABLE TO PUT THOSE IMAGES INTO THE PATIENT'S RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290287 * CAMERA, SURGICAL AND ACCESSORIES LMC SONY ELECTRONICS INC., MEDICAL SYSTEMS DIVISION UP-5600MDU/S *

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR