BEUDAMED
    FDA Adverse Event Summary report: N

    PENTAX

    MDR report key: 5300231 · Received December 15, 2015

    Report

    Report Number
    9610877-2015-00081
    Date Received
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PENTAX OF AMERICA, INC. FILED MDR 2518897-2014-00006 BASED ON VIDEO GASTROSCOPE MODEL EG-2970K/SERIAL (B)(4) INVOLVED IN AN EVENT. THE MDR INCLUDED INFORMATION ON THREE PATIENTS IN WHICH PROCEDURES WERE PERFORMED POTENTIALLY WITH A BRUSH FRAGMENT LODGED INSIDE THE VIDEO GASTROSCOPE. TO ENSURE FULL COMPLIANCE WITH FDA'S EXPECTATION OF ONE PATIENT PER NUMBER, PENTAX OF AMERICA, INC. IS SUBMITTING TWO ADDITIONAL MDRS TO ENSURE EACH PATIENT IS UNIQUELY IDENTIFIED/REPORTED. MDR 9610877-2015-00081 IS BEING SUBMITTED TO ENSURE THE SECOND PATIENT IS UNIQUELY IDENTIFIED/REPORTED. GOING FORWARD, PENTAX MEDICAL WILL REPORT SUPPLEMENTAL INFORMATION ON THIS PATIENT EXCLUSIVELY TO THIS MDR. MDR 2518897-2014-00006 INCLUDES INFORMATION PREVIOUSLY REPORTED ON THE PATIENT IDENTIFIED IN THIS MDR AND ON THE DEVICE INVOLVED IN THE EVENT (VIDEO GASTROSCOPE MODEL EG-2970K/SERIAL (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826400 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2970K

    Patients

    Seq Age Sex Outcome Treatment
    1