BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 5394664 · Received January 27, 2016

    Report

    Report Number
    9610877-2016-00001
    Event Type
    Malfunction
    Date Received
    January 27, 2016
    Report Date
    January 5, 2016
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K092710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015036).

    Additional Manufacturer Narrative · 0

    (B)(4). (EXEMPTION NUMBER E2015036).

    Description of Event or Problem · 0

    ON (B)(6) 2016, PENTAX MEDICAL RECEIVED A CUSTOMER REPORT STATING VIDEO DUODENOSCOPE MODEL ED-3490TK/SERIAL (B)(4) TESTED POSITIVE FOR BLOOD AND PROTEIN VIA THE HEALTH MARK INDUSTRIES CHANNEL CHECK PROCESS. PREVIOUS COMMUNICATION WITH THE FACILITY CONFIRMED THAT EVERY DUODENOSCOPE IS TESTED FOR CARBOHYDRATES, PROTEIN, AND BLOOD PRIOR TO BEING USED IN A PATIENT CARE SETTING (REFER TO MDR# 2518897-2015-00025), AS A RISK MITIGATION STEP.

    Description of Event or Problem · 0

    THE DUODENOSCOPE WAS SENT TO PENTAX FOR EVALUATION. THE PENTAX SERVICE INSPECTIONAL FINDINGS INCLUDED THE FOLLOWING: DISTAL CAP/CASE SCRATCHED. DISTAL CAP MISSING SILICONE. REMOTE CONTROL BUTTON CASE LID SCRATCHED. REMOTE CONTROL BUTTON CASE SCRATCHED. REPAIRS WERE PERFORMED ON THE DUODENOSCOPE, WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: DISTAL CASE/CAP. O-RING. BENDING RUBBER. OPERATION CHANNEL. AIR/WATER TUBE. INSULATION RING ASSY. BIOPSY INLET T-PIECE. A DEVICE HISTORY REVIEW WAS PERFORMED ON (B)(6) 2016 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. THE CAUSE OF THE CHANNEL CHECK POSITIVE READING IS UNKNOWN. THE DEVICE WAS RETURNED TO THE CUSTOMER ON (B)(6) 2015. SINCE NO FURTHER INFORMATION REGARDING THIS EVENT HAS BEEN RECEIVED FROM THE FACILITY, PENTAX MEDICAL CLOSED THE INVESTIGATION ON 03/09/2017 AND CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51671 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1