BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 5499162 · Received March 14, 2016

    Report

    Report Number
    9610877-2016-00058
    Event Type
    Malfunction
    Date Received
    March 14, 2016
    Report Date
    October 14, 2013
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    PMA / PMN Number
    K130247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 FOR AN EVENT WHICH OCCURRED IN (B)(6) STATING "PERSISTENCE OF INFECTION OF OUR ENDOSCOPE OF PUNCTURE EG-3870UTK OF PENTAX BRAND; SINCE MORE THAN A MONTH, BACTERIOLOGICAL SAMPLES ON THIS DEVICE SHOW KLEBSIELLA PNEUMONIAE INFECTION, WHICH CANNOT BE RESOLVED DESPITE THE REPEATED USE OF PAA", INVOLVING PENTAX MODEL EG-3870UTK/SERIAL A120104. THE REPORT ISSUED BY LABORATORIE BIO-CLIN IN (B)(6) SHOWS 14 UFC OF KLEBSIELLA PNEUMONIAE WERE FOUND IN THE OPERATOR CHANNEL AND >100 UFC OF KLEBSIELLA PNEUMONIAE WERE FOUND IN OTHER CHANNELS.

    Additional Manufacturer Narrative · 1

    (B)(4). EXEMPTION NUMBER E2015036.

    Description of Event or Problem · 1

    PENTAX MEDICAL FRANCE WAS NOTIFIED BY THE CUSTOMER THAT PENTAX MODEL EG-3870UTK/SERIAL (B)(4) IS CONTAMINATED AFTER A REPAIR PERFORMED IN (B)(6) 2013. THE CUSTOMER RETURNED THE GASTROSCOPE FOR DECONTAMINATION ON (B)(6) 2013. THE DATE OF AWARENESS FOR THIS MDR IS BEING REVISED TO (B)(6) 2013 BASED ON THIS INFORMATION. AFTER REPROCESSING AND SAMPLING AT PENTAX FRANCE, THE BIOLOGICAL RESULTS INDICATED 14 UFC IN THE OPERATION CHANNEL AND >100UFC IN OTHER CHANNEL. THE CUSTOMER ACCEPTED A REPAIR WHICH INVOLVED CHANNEL REPLACEMENT ON (B)(6) 2013. EMAIL COMMUNICATIONS WERE HELD BETWEEN PENTAX (B)(4) FROM 19/NOV/2013 TO 28/FEB/2014 PENTAX (B)(4) AND THE CUSTOMER REGARDING AER, REPROCESSING CHEMICALS, AER ADAPTORS AND STORAGE, HOWEVER ROOT CAUSE OF THE CONTAMINATION WAS UNABLE TO BE DETERMINED. ON 21/JUL/2016, A DEVICE HISTORY REVIEW WAS PERFORMED WHICH CONFIRMED THE GASTROSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. IN ADDITION, 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
    153852 PENTAX ULTRASOUND VIDEO GASTROSCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG-3870UTK

    Patients

    Seq Age Sex Outcome Treatment
    1