BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 7448206 · Received April 20, 2018

    Report

    Report Number
    9610877-2018-00112
    Event Type
    Malfunction
    Date Received
    April 20, 2018
    Report Date
    January 16, 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

    (B)(4). PENTAX TOKYO OFFICE (EXEMPTION NUMBER: E2015036.

    Description of Event or Problem · 0

    ON 16-JAN-2018, PENTAX MEDICAL BECAME AWARE OF THE IDENTIFICATION RESULTS OF SAMPLING PERFORMED ON (B)(6) 2017 ON PENTAX MODEL ED-3490TK/(B)(4). THE SAMPLING PERFORMED ON (B)(6) 2017 YIELDED A TOTAL OF 106 CFU COMPRISED OF 1 ISOLATE: - NEGATIVE RODS, PSEUDOMONAS AERUGINOSA. THE DUODENOSCOPE WAS RETURNED TO PENTAX ON 14-NOV-2017 (REFER TO MDR 9610877-2017-00669). THE PENTAX INSPECTIONAL FINDINGS INCLUDED THE FOLLOWING: DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION, HOLE IN AND LEAK AT #4 REMOTE CONTROL BUTTON COVER, HOLE IN AND LEAK AT #2 REMOTE CONTROL BUTTON COVER, AIR/WATER SOCKET CYLINDER O-RING CHIPPED, ELEVATOR BODY, SCREW LOOSE, FAILED WET AND DRY LEAK TEST, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR OR CONTROL BODY. REPAIRS WERE PERFORMED ON THE DUODENOSCOPE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: BIOPSY INLET T-PIECE PB-FREE, AIR/WATER TUBE, DEFLECTOR BODY, DEFLECTOR BODY LINK, DEFLECTOR OPERATING WIRE, OPERATION CHANNEL, BENDING RUBBER, DISTAL CASE/CAP, REMOTE CONTROL BUTTON (1), DEFLECTOR BODY ATTACHING SCREW, DEFLECTOR OP WIRE ADJUSTING SCREW. THE DUODENOSCOPE WAS SHIPPED BACK TO THE CUSTOMER ON 12-JAN-2018.

    Description of Event or Problem · 0

    ON 05/30/2018, DEVICE HISTORY REVIEW WAS PERFORMED CONFIRMING THE DUODENOSCOPE WAS MANUFACTURED UNDER NORMAL CONDITIONS, HOWEVER IT FAILED DURING FINAL INSPECTION DUE TO INSERTION FLEXIBLE TUBE(IFT) SCRATCH. IT WAS REWORKED BY EXCHANGING THE IFT, AFTER WHICH IT PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO CONCESSIONS AND THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. PENTAX MEDICAL MODEL ED-3490TK/(B)(4) HAS BEEN ROUTINELY SERVICED BY A PENTAX MEDICAL FACILITY SINCE THE DUODENOSCOPE WAS SHIPPED TO THE CUSTOMER ON 12/13/2012. CORRECTIVE ACTION PAI-18-030072, WAS INITIATED ON 04/10/2018 FOR A SAMPLING AND CULTURING STUDY TREND AND IS STILL IN 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
    289282 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1