BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 14266528 · Received May 3, 2022

    Report

    Report Number
    9610877-2022-00498
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Date of Event
    April 15, 2022
    Report Date
    July 13, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    GCQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: H4:DEVICE MANUFACTURE DATE. EVALUATION SUMMARY: WE INVESTIGATED THE DEFECTIVE DEVICE. AS A RESULT OF THE INVESTIGATION, THE REPORTED DEFECT WAS NOT REPRODUCED. IT WAS CONFIRMED THAT IT WAS A NORMAL PRODUCT. WE ALSO CHECKED THE DHR AND CONFIRMED THAT THERE WAS NO PROBLEM.

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS NOT DISTRIBUTED IN US SO THAT UNIQUE IDENTIFIER IS BLANK. THIS DEVICE IS NOT DISTRIBUTED IN THE USA, THEREFORE THE PMA/510(K) NUMBER IS NOT APPLICABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    DIFFICULT TO OPEN AND CLOSE THE CUP WHEN I CHECKED THE OPENING AND CLOSING OF FORCEPS BEFORE INSERTING THE ENDOSCOPE, IT DID NOT OPEN. THERE WAS NO REPORT OF PATIENT HARM. THE TIME OF EVENT IS BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216845 PENTAX HOT HEMOSTASIS FORCEPS GCQ HOYA CORPORATION PENTAX TOKYO OFFICE HDB2418W

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown