BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12028186 · Received June 18, 2021

    Report

    Report Number
    9610877-2021-00113
    Event Type
    Malfunction
    Date Received
    June 18, 2021
    Report Date
    June 1, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    UDI-DI
    04961333148226
    PMA / PMN Number
    K131946
    Removal / Correction Number
    NOT ISSUED YET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    PENTAX OF AMERICA INITIATED FIELD CORRECTION 2017-008-C WHICH INCLUDED INSPECTION OF THE SUCTION ARM ON AFFECTED MODELS PURSUANT TO PREDEFINED INSPECTION CRITERIA (QS-397). THE OBJECTIVE OF THE INSPECTION WAS TO LOCATE PART C255-AB171 (SUCTION ARM) AND VERIFY IT IS NOT LOOSE. IF PART C255-AB171 (SUCTION ARM) IS FOUND LOOSE, THE DEVICE WAS CONSIDERED TO FAIL THE INSPECTION CRITERIA. THE LOANER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 28-MAY-2021. INSPECTION OF THE UNIT WAS PERFORMED ON (B)(6) 2021 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: SUCTION ARM LOOSE, PASSED DRY LEAK TEST, CUSTOMER COMPLAINT NOT STATED, PASSED WET LEAK TEST, UMBILICAL CABLE SHORT, BUCKLED AT CONTROL BODY SIDE. INSPECTION OF THE SUCTION ARM WAS PERFORMED UNDER SERVICE REPAIR NUMBER (B)(4) AND THE DEVICE FAILED THE INSPECTION CRITERIA. THE ENDOSCOPE'S REPAIRS TO BE PERFORMED WHERE THE LOOSE SUCTION ARM WILL BE CORRECTED, AND THE UNIT RETURNED TO THE LOANER INVENTORY UPON COMPLETION. THE ENDOSCOPE REPAIR INCLUDES THE FOLLOWING COMPONENTS: O-RING(1.25X3.5), SUCTION CONNECTION TUBE, O-RING(1.2X3.5). PENTAX MODEL EB-1970UK, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2012 THE ENDOSCOPE WAS APPROVAL BY FINAL QC ON 15-JUN-2021 AND WAS PUT BACK INTO LOANER INVENTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920819 PENTAX VIDEO BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE EB-1970UK 04961333148226

    Patients

    Seq Age Sex Outcome Treatment
    1