BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12306913 · Received August 11, 2021

    Report

    Report Number
    9610877-2021-00395
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    January 1, 2021
    Report Date
    August 11, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333129492
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    PENTAX MEDICAL BECAME AWARE OF A REPORT FOR AN EVENT WHICH OCCURRED IN (B)(6) STATING, "LCB BROKEN, REDUCED " INVOLVING PENTAX MODEL EG-2990I/SERIAL (B)(4). THE EVENT WAS REPORTED TO HAVE OCCURRED PRIOR TO USE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. THE DEVICE WAS RETURNED TO PENTAX MEDICAL (B)(4) SERVICE WORKSHOP WHERE THE FOLLOWING WAS CONFIRMED: LCB BROKEN, REDUCED TO 85%, 0%. LG PRONG TOP ASSY LOOSENED. THE LCB WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203458 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2990I 04961333129492

    Patients

    Seq Age Sex Outcome Treatment
    1