BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13959200 · Received March 31, 2022

    Report

    Report Number
    9610877-2022-00440
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 18, 2022
    Report Date
    June 7, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: NO VISIBLE DEFECT AT THE VALVES DETECTED. THE VALVES HAVE BEEN REPLACED AND WORK WITHOUT ANY PROBLEM. CORRECTION INFORMATION: G6: FOLLOW UP #1. H6: CODING CHANGED BASED ON THE INVESTIGATION RESULT.

    Description of Event or Problem · 0

    TWO OF-B206 PISTONS HAVE PERMANENT SUCTION VIA THE BALLOON CHANNEL CAUSING A HICKEY ON THE MUCOSA IN PARTICULAR WITH THE EG36-J10UR REPORTED BY THE DOCTOR SEVERAL MONTHS AGO. A TEST WITH A NEW PISTON CORRECTED THE PROBLEM. OF-B206 DELIVERED WITH EG38-J10UT A120592 ON (B)(6) 2021 AND WITH EG36-J10UR A120194 ON (B)(6) 2021. THE PISTONS DO NOT FOLLOW THE ENDOSCOPE AND CAN BE INTERCHANGED. NOTE THAT THE CUSTOMER DOES NOT USE A BALLOON. NOBODY HURT. WE ARE WAITING FOR PICTURES AND DETAILED DEFECT DESCRIPTIONS. THERE WAS NO REPORT OF PATIENT HARM. THE TIME OF EVENT IS DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2189778 PENTAX SUCTION/ SUCTION CHANNEL/ CONTROL VALVE FOR EG34-J10U ODG HOYA CORPORATION PENTAX TOKYO OFFICE OF-B206

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown