BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12421631 · Received September 3, 2021

    Report

    Report Number
    9610877-2021-00575
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Report Date
    September 3, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    EOB
    UDI-DI
    04961333239795
    PMA / PMN Number
    K171011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT WHICH OCCURRED IN THE UNITED STATES WITH THE DESCRIPTION OF "NO VIDEO/ERROR MSG, SCOPE NOT CONN." INVOLVING PENTAX MEDICAL ENDOSCOPE MODEL VNL9-CP, SERIAL NUMBER (B)(4). THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 09-AUG-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN FOUND IMAGE BLACKOUT CONFIRMING THE CUSTOMER COMPLAINT AND ALSO DOCUMENTED THE FOLLOWING INSPECTION FINDINGS: CONTROL BODY VIVIDEO SIGNS OF SEVERE CORROSION, PASSED DRY LEAK TEST, PASSED WET LEAK TEST, IFT ASSY WITH BENDING RUBBER BUKCLE AT END OF ROOTBRACE, CONTROL BODY VIVIDEO SIGNS OF FLUID INVASION. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AND SEALS, IFT ASSY W/BENDING RUBBER, RS2 CONTROL BUTTON WITH PCB, R2S MODULE, R2S LED MODULE, UMBILICAL CABLE W/O JST CONNECTOR, JST CONNECTOR (SET OF 20PCS), R2S SWITCH CABLE, R2S LED MODULE. MODEL VNL9-CP, SERIAL NUMBER (B)(4) HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE. THE ENDOSCOPE IS AWAITING REPAIR AND APPROVED BY FINAL QC AS OF 03-SEP-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321320 PENTAX VIDEO NASOLARYNGOSCOPE (FOR VIVIDEO) EOB HOYA CORPORATION PENTAX TOKYO OFFICE VNL9-CP 04961333239795

    Patients

    Seq Age Sex Outcome Treatment
    1