BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9199766 · Received October 16, 2019

    Report

    Report Number
    9610877-2019-01509
    Event Type
    Malfunction
    Date Received
    October 16, 2019
    Date of Event
    September 6, 2019
    Report Date
    September 18, 2019
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K161222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT PROBLEM AND EVALUATION CODES: (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL BECAME AWARE OF A REPORT ON 18-SEP-2019 STATING PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED-3490TK, SERIAL NUMBER (B)(4), CULTURED POSITIVE AFTER SAMPLING PERFORMED ON (B)(6) 2019. THE SAMPLING PERFORMED ON (B)(6) 2019 IDENTIFIED COLONY FORMING UNITS(CFU) DESIGNATED AS "TNTC" (TOO NUMEROUS TO COUNT) COMPRISING THE FOLLOWING 2 ISOLATES: 1 - POSITIVE RODS - BACILLUS SIMPLEX, 2 - POSITIVE RODS - BACILLUS INFANTIS. STUDY NUMBER: (B)(6). THE LONG TERM LOANER DUODENOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 19-SEP-2019. THE DUODENOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE ON 25-SEP-2019 AND THE FOLLOWING INSPECTION FINDINGS WERE DOCUMENTED: PRIMARY OPERATION CHANNEL RESISTANCE, DISTAL TIP ANNUAL MAINTENANCE, DISTAL CAP - FIXED TYPE PASSED EPOXY SEAL INTEGRITY INSPECTION, PASSED DRY LEAK TEST, DISTAL CAP/ CASE CRACKED, PASSED WET LEAK TEST, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY. REPAIRS WERE PERFORMED ON THE DUODENOSCOPE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, OPERATION CHANNEL, BENDING RUBBER, DISTAL CASE/CAP, BIOPSY INLET T-PIECE PB-FREE, AIR/WATER SUPPLY TUBE LG, JET SUPPLY TUBE LG, SUCTION CHANNEL LG, O-RING(0.5X1.3). A DEVICE HISTORY RECORD(DHR) WAS PREVIOUSLY PERFORMED ON 27-JUN-2019 UNDER FORM NUMBER (B)(4). THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 26-APR-2016 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 FOR 26-APR-2016. PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 28-JUN-2016. THE VIDEO DUODENOSCOPE IS CURRENTLY AWAITING QC FINAL APPROVAL AND ORGANIC RESAMPLING AS OF 16-OCT-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990406 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1