BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 2253680 · Received September 6, 2011

    Report

    Report Number
    2518897-2011-00003
    Event Type
    Injury
    Date Received
    September 6, 2011
    Date of Event
    August 4, 2011
    Report Date
    September 6, 2011
    Manufacturer
    PENTAX MEDICAL COMPANY
    Product Code
    KOG
    PMA / PMN Number
    K934918
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY RETURNED THE PENTAX (B)(4) VIDEO COLONOSCOPE AND (B)(4) VIDEO PROCESSOR INVOLVED IN THE EVENT FOR EVALUATION. RE: (B)(4) VIDEO COLONOSCOPE. ALL FUNCTIONS PASS INSPECTION. RE: (B)(4) VIDEO PROCESSOR. LOOSE ENDOSCOPE LOCK ARM, THE MECHANISM HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. DENT ON UNIT TOP. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE ROOT CAUSE HAS BEEN IDENTIFIED. EVALUATION: RESULTS: MECHANISM.

    Description of Event or Problem · 1

    DURING A COLONOSCOPY PROCEDURE THE PHYSICIAN WAS INTRODUCING A SNARE INTO THE ENDOSCOPE OPERATION CHANNEL, THE PHYSICIAN REPORTED THE VIDEO IMAGE 'FROZE' MOMENTARILY, WHEN THE LIVE IMAGE RETURNED THE PHYSICIAN OBSERVED A LACERATION, THE PT REQUIRED 5 CLIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTAX VIDEO PROCESSOR KOG PENTAX MEDICAL COMPANY EPK-700

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PENTAX (B)(4) VIDEO COLONOSCOPE| BOSTON SCIENTIFIC: MODEL 6269 MED/ SMALL SNARE