BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 7363136 · Received March 22, 2018

    Report

    Report Number
    9610877-2018-00015
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Report Date
    February 21, 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

    REPORT SOURCE CONTINUED: 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 7 CFU COMPRISED OF 4 ISOLATES (POSITIVE COCCI; MICROCOCCUS LUTEUS, NEGATIVE RODS; PAENIBACILLUS LAUTUS, NEGATIVE RODS; PAENIBACILLUS LAUTUS, NEGATIVE COCCI; PSYCHROBACTER FAECALIS). THE DUODENOSCOPE WAS RETURNED TO PENTAX MEDICAL FOR EVALUATION. THE PENTAX MEDICAL SERVICE INSPECTION FINDINGS INCLUDED THE FOLLOWING: OPERATION CHANNEL - PRIMARY SLICE BY ACCESSORY. DISTAL CAP - FIXED TYPE FAILED SEAL INTEGRITY INSPECTION. INSERTION TUBE LUMP AT STAGE 1. PASSED DRY/WET LEAK TEST. LIGHTGUIDE PRONG COVER GLASS SET LOOSE. LIGHT CARRYING BUNDLE DISTAL COVER GLASS MIDDLE SCRATCHED. UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE. FLUID INVASION NOT OBSERVED IN PVE CONNECTOR OR IN CONTROL BODY. SUCTION TUBE MILD RESISTANCE. 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. BODY SIDE COVER FOR DEFLECTOR. DEFLECTOR BODY ATTACHING SCREW. THE DUODENOSCOPE WAS SHIPPED BACK TO THE CUSTOMER ON 19-MAR-2018.

    Description of Event or Problem · 0

    ON 12/MAR/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 ED-3490TK/SERIAL (B)(4) HAS BEEN ROUTINELY SERVICED BY A PENTAX FACILITY SINCE THE DEVICE WAS SHIPPED TO THE CUSTOMER ON 04/28/2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205256 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1