BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12708693 · Received October 27, 2021

    Report

    Report Number
    9610877-2021-01364
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    June 1, 2021
    Report Date
    October 27, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: THE INVESTIGATION WAS MADE BY PENTAX (B)(4). PENTAX (B)(4) CONFIRMED THAT THERE WAS A MANUFACTURING STICKER ON THE SCOPE. THEREFORE THERE IS NO PARTICULAR PROBLEM.

    Description of Event or Problem · 0

    DURING THE STORAGE IT WAS DETECTED, THAT THERE ARE STICKERS ON THE NEW AND STERIL PACKED SCOPES. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604916 PENTAX ENDOSCOPE, FLEXIBLE GCQ HOYA CORPORATION PENTAX TOKYO OFFICE EB15-S01 EB5A001

    Patients

    Seq Age Sex Outcome Treatment
    1