BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 7379542 · Received March 28, 2018

    Report

    Report Number
    9610877-2018-00106
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Report Date
    February 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). EVALUATIONS CODES: METHOD CODES: ACTUAL DEVICE EVALUATED FDA 10. RESULTS CODES: WEAR PROBLEM FDA 140. CONCLUSION CODES: DEVICE REPAIRED AND RETURNED FDA 63.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT STATING PENTAX MODEL ED-3490TK/(B)(4) CULTURED POSITIVE AFTER SAMPLING PERFORMED ON (B)(6) 2018. THE SAMPLING PERFORMED ON (B)(6) 2018 YIELDED A TOTAL OF 8 CFU COMPRISED OF THE FOLLOWING 5 ISOLATES: POSITIVE RODS, AMMONIPHILUS RESINAE, POSITIVE RODS, BACILLUS CEREUS, POSITIVE RODS, BACILLUS CIRCULANS, POSITIVE COCCI, MICROCCOCUS LUTEUS, POSITIVE RODS, PAENIBACILLUS WOOSONGENSIS.

    Description of Event or Problem · 0

    ON 03/27/2018 PENTAX OF AMERICA, INC(PAI) CUSTOMER SERVICE ISSUED A RMA NUMBER (B)(4) FOR THE DUODENOSCOPE TO BE RETURNED TO PENTAX MEDICAL FOR EVALUATION. ON 04/04/2018 THE DUODENOSCOPE WAS INSPECTED BY A PAI TECHNICIAN UNDER THE SERVICE ORDER NUMBER 3109411. THE PENTAX MEDICAL SERVICE INSPECTION FINDINGS INCLUDED THE FOLLOWING: UMBILICAL CABLE SINGLE CRACK UNDER ROOT BRACE. DISTAL CAP - FIXED TYPE C1- ZONE C - SEAL INTEGRITY INTACT. DISTAL CAP - FIXED TYPE D1- ZONE D - SEAL INTEGRITY INTACT. DISTAL CAP - FIXED TYPE E1- ZONE E - SEAL INTEGRITY INTACT. DISTAL CAP - FIXED TYPE PASSED SEAL INTEGRITY INSPECTION. PASSED WET/DRY LEAK TEST. DISTAL CAP - FIXED TYPE B1- ZONE B - SEAL INTEGRITY INTACT. LIGHT CARRYING BUNDLE DISTAL COVER GLASS MIDDLE SCRATCHED. FLUID INVASION NOT OBSERVED IN PVE CONNECTOR. FLUID INVASION NOT OBSERVED IN CONTROL BODY. INSERTION TUBE MILD SCRATCHES AT STAGE 1. DISTAL CAP - FIXED TYPE A1- ZONE A- SEAL INTEGRITY INTACT. ON 05/16/2018, A DEVICE HISTORY REVIEW WAS PERFORMED CONFIRMING THE ENDOSCOPE 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 MODEL ED-3490TK/SERIAL (B)(4) HAS BEEN ROUTINELY SERVICED BY A PENTAX FACILITY SINCE THE DEVICE WAS SHIPPED TO THE CUSTOMER ON 12/13/2012. CORRECTIVE ACTION (B)(4), 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
    221852 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1