BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11355475 · Received February 19, 2021

    Report

    Report Number
    9610877-2021-00052
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Report Date
    January 26, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333229611
    PMA / PMN Number
    K161222
    Removal / Correction Number
    NOT ISSUED YET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 25-JAN-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER (B)(4) WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 26-JAN-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) DISTAL SID, DISTAL CAP/ CASE CRACKED, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, FAILED WET LEAK TEST, SUCTION TUBE RESISTANCE, FAILED DRY LEAK TEST, SEGMENT SCREW LOOSE AT INSERTION TUBE, UMBILICAL CABLE,MILD CRUSH. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH THE FOLLOWING PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAY COIL, OPERATION CHANNEL, BENDING RUBBER, DISTAL CASE/CAP, SUCTION CHANNEL LG, O-RING(0.5X1.3) IMP-1. MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON (B)(6) 2015. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC AS OF 19-FEB-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249629 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK 04961333229611

    Patients

    Seq Age Sex Outcome Treatment
    1