BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENTAX

    MDR report key: 2526991 · Received March 7, 2011

    Report

    Report Number
    2518897-2011-00001
    Event Type
    Other
    Date Received
    March 7, 2011
    Date of Event
    December 2, 2010
    Report Date
    February 26, 2011
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    FDS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED: DURING COLONOSCOPY, ENDOSCOPY PENTAX PROCESSOR MALFUNCTIONED. IMAGES DID NOT CAPTURE WHEN MD TRIED TO CAPTURE THEM, AND THE VIDEO DISPLAY MONITOR/ PROCESSOR FROZE WITH A STILL IMAGE BEING DISPLAYED. ONLY A SMALL PICTURE-IN-PICTURE APPEARED ON THE UPPER RIGHT CORNER OF MONITOR. PROCESSOR/ ENDO CART SHUT DOWN/ REBOOTED, WHICH CLEARED THE ERROR/ MALFUNCTION. PROCEDURE CONTINUED WITHOUT FURTHER INCIDENT. REFERENCE USER FACILITY REPORT # (B)(4). UNIT EVALUATED AT REPAIR CENTER. USER SITE VISITED (B)(4) 2011; POSSIBLE ELECTROMAGNETIC INTERFERENCE FROM ANOTHER DEVICE IN THE PROCEDURE ROOM (ELECTRO CAUTERY DEVICE) - USER ADVISED TO HAVE THE DEVICE EVALUATED BY THE ORIGINAL EQUIPMENT MFR. POSSIBLE CPU FAILURE - CPU REPLACE ON THE POSSIBILITY OF COMPONENT FAILURE. POSSIBLE ANCILLARY IMAGE ACQUISITION SYSTEM FAILURE - REINSTRUCTED USER TO MONITOR IMAGE FILING SYSTEM DURING PROCEDURE. POSSIBLE CABLE FAILURE - USER REINSTRUCTED IN PROPER CABLING AND TROUBLESHOOTING. POSSIBLE USER ERROR - USER REINTRUCTED IN THE OPERATION OF THE FREEZE FEATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX VIDEO PROCESSOR FDS PENTAX MEDICAL COMPANY EPK-I *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other