BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 5499227 · Received March 14, 2016

    Report

    Report Number
    9610877-2016-00079
    Event Type
    Injury
    Date Received
    March 14, 2016
    Date of Event
    October 8, 2013
    Report Date
    October 14, 2013
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    PMA / PMN Number
    REFER TO H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PENTAX GASTROSCOPE MODEL EG-2985K IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. MDR 9610877-2016-00070 IS BEING SUBMITTED FOR PENTAX DISPOSABLE TRI-BRISTLE CLEANING BRUSH MODEL CS-6021T/LOT 0051063. MDR 9610877-2016-00079 IS BEING SUBMITTED FOR PENTAX GASTROSCOPE MODEL EG-2985K/SERIAL (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 FOR AN EVENT WHICH OCCURRED IN FRANCE STATING WHILE PERFORMING A PROCEDURE WITH PENTAX GASTROSCOPE MODEL EG-2985K/SERIAL (B)(4), A PIECE OF A PENTAX DISPOSABLE TRI-BRISTLE CLEANING BRUSH MODEL CS-6021T/LOT 0051063 WAS FOUND IN THE STOMACH OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    (B)(4). PENTAX TOKYO OFFICE (EXEMPTION NUMBER E2015036). MDR 9610877-2016-00070 IS BEING SUBMITTED FOR PENTAX DISPOSABLE TRI-BRISTLE CLEANING BRUSH MODEL CS-6021T/LOT 0051063. MDR 9610877-2016-00079 IS BEING SUBMITTED FOR PENTAX GASTROSCOPE MODEL EG-2985K/SERIAL (B)(4).

    Description of Event or Problem · 1

    THE VIDEO GASTROSCOPE WAS NOT RETURNED TO PENTAX MEDICAL FOR EVALUATION. ON 10/26/2016, A 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 MEDICAL CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154520 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2985K

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention