BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 15883190 · Received November 29, 2022

    Report

    Report Number
    9610877-2022-00649
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    October 31, 2022
    Report Date
    January 31, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    MNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION G2:REPORT SOURCE G6: FOLLOW UP #1 H2:IF FOLLOW-UP, WHAT TYPE? H3:DEVICE EVALUATED BY MANUFACTURE H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT EVALUATION SUMMARY BASED ON THE REPORTED CONTENT, IT WAS DETERMINED THAT A LARGE AMOUNT OF SILICONE OIL THAT HAD BEEN APPLIED TO THE SUCTION VALVE (PRODUCT OF ANOTHER COMPANY) ADHERED TO THE SUCTION PIPE, CAUSING RESISTANCE WHEN THE BRUSH WAS INSERTED. (THIS SUCTION VALVE IS A DISPOSABLE PRODUCT OF ANOTHER COMPANY, AND COMPATIBILITY HAS NOT BEEN CONFIRMED.)

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION. 510K NUMBER IS NOT APPLICABLE BECAUSE OF ACCESSARY.

    Description of Event or Problem · 0

    NO KNOWN ADVERSE EVENT. PER THE INITIAL REPORT, CUSTOMER STATED THAT THE LONG CLEANING BRUSHES CS-6021T WERE DIFFICULT TO PULL THROUGH THE ENDOSCOPES. THEY OBSERVED AND VERIFIED THAT THEY IN FACT WERE DIFFICULT AND DETERMINED ALL BRUSHES THAT THEY HAD IN STOCK ARE FROM THE SAME LOT NUMBER 0020152. THEY HAVE RETURNED THE REMAINING BRUSHES TO PENTAX. THIS EVENT OCCURRED AT THE TIME TO REPROCESS. THERE WAS NO REPORT OF PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2292478 PENTAX CLEANING BRUSH MNL HOYA CORPORATION PENTAX TOKYO OFFICE CS6021T 0020152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown