BEUDAMED
    FDA Adverse Event Summary report: N

    PENTAX

    MDR report key: 5300228 · Received December 15, 2015

    Report

    Report Number
    9610877-2015-00080
    Date Received
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    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 2518897-2013-00002 BASED ON VIDEO COLONOSCOPE MODEL EC-3890LI/SERIAL (B)(4) INVOLVED IN AN EVENT. THE MDR INCLUDED INFORMATION ON TWO PATIENTS IN WHICH COLONOSCOPIES WERE PERFORMED POTENTIALLY WITH A BRUSH FRAGMENT LODGED INSIDE THE VIDEO COLONOSCOPE. TO ENSURE FULL COMPLIANCE WITH FDA'S EXPECTATION OF ONE PATIENT PER NUMBER, PENTAX OF AMERICA, INC. IS SUBMITTING ONE ADDITIONAL MDR TO ENSURE EACH PATIENT IS UNIQUELY IDENTIFIED/REPORTED. MDR 9610877-2015-00080 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 2518897-2013-00002 INCLUDES INFORMATION PREVIOUSLY REPORTED ON THE PATIENT IDENTIFIED IN THIS MDR AND ON THE DEVICE INVOLVED IN THE EVENT (VIDEO COLONOSCOPE MODEL EC-3890LI/SERIAL (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826502 PENTAX VIDEO COLONOSCOPE FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC-3890LI

    Patients

    Seq Age Sex Outcome Treatment
    1