BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 5498964 · Received March 14, 2016

    Report

    Report Number
    9610877-2016-00071
    Event Type
    Injury
    Date Received
    March 14, 2016
    Report Date
    January 14, 2014
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    PMA / PMN Number
    K131902
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS MDR WAS INITIATED AS PART OF A CAPA-DRIVEN REMEDIATION EFFORT RELATED TO FILING OF MDRS FOR COMPLAINTS/EVENTS OUTSIDE OF THE US (OUS). AS PART OF THIS REMEDIATION, PENTAX MEDICAL PERFORMED A RETROSPECTIVE MDR ASSESSMENT OF ALL OUS EVENTS/COMPLAINTS RECEIVED SINCE JAN 2013. THE RETROSPECTIVE ASSESSMENT OF THIS EVENT PROMPTED PENTAX MEDICAL TO FILE THIS REPORT. (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A REPORT RECEIVED FROM PENTAX (B)(4) STATING "INJURY TO STOMACH LINING DURING EXAM INVOLVING PENTAX MODEL EC-3490K/SERIAL (B)(4)".

    Additional Manufacturer Narrative · 1

    HOYA CORPORATION PENTAX (B)(4) OFFICE, SPECIFICATION DEVELOPER, REGISTRATION NO. 9610877 PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. 2518897. PENTAX OF AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX (B)(4) OFFICE (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 1

    THE GASTROSCOPE WAS RETURNED TO PENTAX (B)(4). THE INSPECTION FOUND A BROKEN DISTAL END BODY WHICH WAS THE RESULT OF NORMAL WEAR AND TEAR. PENTAX (B)(4) QUERIED THE FACILITY FOR ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT CONDITION. NO RESPONSE WAS RECEIVED FROM THE FACILITY. ON 21/JUL/2016, DEVICE HISTORY REVIEW WAS PERFORMED CONFIRMING THE GASTROSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. NO FURTHER INFORMATION HAS BEEN RECEIVED FOR THIS EVENT, THEREFORE PENTAX CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154586 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-3490K

    Patients

    Seq Age Sex Outcome Treatment
    1 Other