BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 2338649 · Received November 10, 2011

    Report

    Report Number
    2518897-2011-00006
    Event Type
    Malfunction
    Date Received
    November 10, 2011
    Date of Event
    October 13, 2011
    Report Date
    November 10, 2011
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    KOG
    PMA / PMN Number
    K934918
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EPK-1000 PASSED FUNCTIONAL TESTING. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE NURSE ON SITE REPORTED: IMAGE ON MONITOR BLACKS OUT PERIODICALLY DURING CAUTERY. NO PT INJURIES HAVE EVER HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX VIDEO PROCESSOR KOG PENTAX MEDICAL COMPANY EPK-1000

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK PENTAX GROUNDING CORD: OL-Z3| (B)(4), LOT 1442561, EXP DATE: 06/2014| PATIENT PLATE: (B)(4)| SONY MONITOR: LMD-2140MD, SN# (B)(4)| BOSTON SCIENTIFIC BIOPSY FORCEPS - HOT: 2.8MM| IRRIGATOR/CAUTERY: CGI-4000, SN# (B)(4)