BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9031720 · Received September 13, 2019

    Report

    Report Number
    9610877-2018-00636
    Event Type
    Malfunction
    Date Received
    September 13, 2019
    Report Date
    December 7, 2018
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOQ
    PMA / PMN Number
    K131028
    Removal / Correction Number
    NOT ISSUED YET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    HOYA CORPORATION PENTAX (B)(4) OFFICE, SPECIFICATION DEVELOPER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC., IMPORTER, REGISTRATION NO. (B)(4). PENTAX OF AMERICA, INC. (IMPORTER) IS SUBMITTING THE REPORT ON BEHALF OF HOYA CORPORATION PENTAX (B)(4) OFFICE (EXEMPTION NUMBER E2015036). (B)(4). NOTES: INITIAL MDR ORIGINALLY SUBMITTED TO THE FDA ON 14DEC2018, HOWEVER, THERE WAS AN ERROR IN FDA ACKNOWLEDGEMENT. RESUBMITTING ON AS PART OF A DELIVERY MESSAGE REVIEW.

    Description of Event or Problem · 1

    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 WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 31/OCT/2018. INSPECTION OF THE DEVICE WAS PERFORMED ON 07/DEC/2018 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: SUCTION ARM LOOSE-(B)(4). PASSED WET LEAK TEST, CUSTOMER COMPLAINT NOT STATED, PASSED DRY LEAK TEST. INSPECTION OF THE SUCTION ARM WAS PERFORMED AND THE DEVICE FAILED THE INSPECTION CRITERIA. THE SCOPE'S REPAIRS TO BE PERFORMED WHERE THE LOOSE SUCTION ARM WILL BE CORRECTED, AND THE UNIT RETURNED TO INVENTORY UPON COMPLETION. PARTS REPLACED: INSERTION/S-NIPPLE ATTACHING SCREW, O-RING(1.25X3.5), SUCTION CONNECTION TUBE, O-RING(1.2X3.5).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812190 PENTAX VIDEO BRONCHOSCOPE EOQ HOYA CORPORATION PENTAX TOKYO OFFICE EB-1570K

    Patients

    Seq Age Sex Outcome Treatment
    1