BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 2621368 · Received June 11, 2012

    Report

    Report Number
    2518897-2012-00003
    Event Type
    Injury
    Date Received
    June 11, 2012
    Date of Event
    April 23, 2012
    Report Date
    June 12, 2012
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    KOG
    PMA / PMN Number
    K934918
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EPK-I VIDEO PROCESSOR INVOLVED IN THIS EVENT WAS EVALUATED BY A PENTAX FIELD SERVICE TECHNICIAN AND IS PERFORMING WITHIN THE MANUFACTURERS SPECIFICATION. POSSIBLE CAUSES FOR THE EVENT INCLUDE: PT CONDITION. OPERATOR SELECTION OF AIR PRESSURE LEVEL. PERFORATION IS KNOWN RISK IN COLONOSCOPY, ESPECIALLY WITH A DOWN STREAM STRICTURE. PENTAX CONSIDERS THIS REPORT CLOSED.

    Description of Event or Problem · 1

    PT PRESENTED WITH BLEEDING. THE PHYSICIAN PERFORMED A COLONOSCOPY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THE PT HAD SIGMOID COLON NARROWING REQUIRING THE USE OF AIR TO AID IN ADVANCING THE ENDOSCOPE. THERE WAS BAROTRAUMA PERFORATION TO THE CECUM. THE PT WAS TRANSFERRED TO SURGERY AND TREATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention PENTAX VIDEO COLONOSCOPE: MODEL EC-3890LI,| SERIAL NUMBER (B)(4)