BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 7448203 · Received April 20, 2018

    Report

    Report Number
    9610877-2018-00110
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Report Date
    March 26, 2018
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K092710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015036).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT STATING PENTAX MODEL ED-3490TK/SERIAL (B)(4) CULTURED POSITIVE AFTER SAMPLING PERFORMED ON (B)(6) 2018. THE SAMPLING PERFORMED ON (B)(6) 2018 YIELDED A TOTAL OF 4 CFU COMPRISED OF 3 ISOLATES: POSITIVE COCCI - MICROCOCCUS LUTEUS, NEGATIVE COCCOBACILLI - ACINETOBACTER SPECIES, POSITIVE RODS - BACILLUS SPECIES. THE DUODENOSCOPE WAS RETURNED TO PENTAX FOR EVALUATION. THE PENTAX INSPECTIONAL FINDINGS INCLUDED THE FOLLOWING: DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION PASSED WET AND DRY LEAK TEST LIGHT CARRYING BUNDLE DISTAL COVER GLASS MIDDLE CHIPPED, REPAIRS WERE PERFORMED ON THE DUODENOSCOPE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: DEFLECTOR BODY LINK O-RING DISTAL CASE/CAP, THE DUODENOSCOPE WAS SHIPPED BACK TO THE CUSTOMER ON 12-APR-2018.

    Description of Event or Problem · 0

    ON (B)(6) 2018, A DEVICE HISTORY REVIEW WAS PERFORMED CONFIRMING THE DUODENOSCOPE 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. PENTAX ED-3490TK/SERIAL: (B)(4) HAS BEEN ROUTINELY SERVICED BY A PENTAX MEDICAL FACILITY SINCE THE DUODENOSCOPE WAS SHIPPED TO THE CUSTOMER ON 02/27/2013. CORRECTIVE ACTION (B)(4) WAS INITIATED ON (B)(6) 2018 FOR A SAMPLING AND CULTURING STUDY TREND AND IS STILL UNDER THE INVESTIGATION PROCESS. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND, THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289280 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1