BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 7448205 · Received April 20, 2018

    Report

    Report Number
    9610877-2018-00111
    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. 9610877 PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. 2518897 PENTAX OF AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX TOKYO OFFICE (EXEMPTION NUMBER E2015036). EVALUATIONS CODES: 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/SERIAL (B)(4) CULTURED POSITIVE AFTER SAMPLING PERFORMED ON (B)(6) 2018. THE SAMPLING PERFORMED ON (B)(6) 2018 YIELDED A TOTAL OF 158 CFU COMPRISED OF 8 ISOLATES: POSITIVE COCCOBACILLI - STREPTOCOCCUS SPECIES. VARIABLE COCCI - NEISSERIA FLAVESCENS. POSITIVE COCCOBACILLI - ROTHIA DENTOCARIOSA. POSITIVE COCCI - STAPHYLOCOCCUS HOMINIS. POSITIVE RODS - ID IN PROCESS. POSITIVE COCCOBACILLI - STREPTOCOCCUS SALIVARIUS. POSITIVE RODS - STREPTOCOCCUS PARASANGUINIS. POSITIVE COCCI - ROTHIA MUCILAGINOSA. THE DUODENOSCOPE WAS RETURNED TO PENTAX FOR EVALUATION. THE PENTAX INSPECTIONAL FINDINGS INCLUDED THE FOLLOWING: -DISTAL CAP - FIXED TYPE PASSED SEAL INTEGRITY INSPECTION. -PASSED WET AND DRY LEAK TEST.

    Description of Event or Problem · 0

    ALTHOUGH THE UNIT PASSED ALL INSPECTIONS, PENTAX MEDICAL REPLACED THE FOLLOWING PARTS: DISTAL CASE/CAP, DEFLECTOR BODY LINK, O-RING(0.5X1.3), BIOPSY INLET T-PIECE PB-FREE, AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, OPERATION CHANNEL, BENDING RUBBER. AFTER COMPLETION OF ALL INSPECTIONS AND REPAIRS, THE DUODENOSCOPE WAS SHIPPED BACK TO THE CUSTOMER ON 04/23/2018 UNDER THE REFERENCE DELIVERY NUMBER: (B)(4). ON 28 MAY 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 MODEL: ED-3490TK/SERIAL: (B)(4) HAS BEEN ROUTINELY SERVICED BY A PENTAX FACILITY SINCE THE DEVICE WAS SHIPPED TO THE CUSTOMER ON 08/21/2017. CORRECTIVE ACTION ISSUE-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
    289281 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1