BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12355925 · Received August 23, 2021

    Report

    Report Number
    9610877-2021-00763
    Event Type
    Malfunction
    Date Received
    August 23, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 23, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    PMA / PMN Number
    K182004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS BEING PROCESSED IN ACCORDANCE WITH DPA-QIP-MDR DECISION BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN THE USA STATING, "NIC CARD PROBLEM" INVOLVING PENTAX MODEL EPK-I5010-US/SERIAL (B)(4). NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION FROM THE FACILITY STATED "WE COULD NOT GET THE MACHINE TO CAPTURE PICTURES WITH PT IDENTIFICATION AND SUBMIT TO CHART. WE HAD TO PUT PICTURES ON A THUMB DRIVE AND CAPTURE THEM UNDER (B)(6) HOSPITAL SYSTEM AS IF THE CASE WAS PERFORMED AT (B)(6)." THE PROCEDURE BEING PERFORMED WAS DIAGNOSTIC AND DUE TO THE EVENT, THERE WAS A 30-MINUTE DELAY AND ADDITIONAL ANESTHESIA WAS REQUIRED. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICE AND NO ADVERSE EVENTS OCCURRED TO THE PATIENT. THE DEVICE WAS RETURNED TO PENTAX. PENTAX SERVICE INSPECTIONAL FINDINGS INCLUDED: PCB FOR I/O-2 RJ45/NETWORK FAILURE, LIMIT SWITCH ACTUATOR PLATE(2) BENT, BALL PLUNGER DAMAGED, ELECTRICAL CONNECTOR WITH WIRING INTERMITTENT CONNECTION, CONTROL PANEL UNIT INOPERATIVE BUTTON(S), SCOPE CONNECTOR HANDLE LOOSE, PCB FOR I/O-1 BOARD MALFUNCTION. REPAIRS WERE PERFORMED ON THE DEVICE WHICH INCLUDED REPLACEMENT OF THE FOLLOWING COMPONENTS: CABLE TO LIMIT SW, BALL PLUNGER, CONTROL PANEL UNIT, SCOPE CONNECTOR ASSY, PCB FOR I/O-1, PCB FOR I/O-2. THE DEVICE WAS SHIPPED BACK TO THE CUSTOMER ON 04/21/2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1253550 PENTAX VIDEO PROCESSOR ODG HOYA CORPORATION PENTAX TOKYO OFFICE EPK-I5010-US

    Patients

    Seq Age Sex Outcome Treatment
    1