BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11783830 · Received May 6, 2021

    Report

    Report Number
    9610877-2021-00060
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Report Date
    April 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)

    Description of Event or Problem · 0

    THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 23-APR-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER 3132783 WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 26-APR-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, PRIMARY OPERATION CHANNEL RESISTANCE, DISTAL TIP ANNUAL MAINTENANCE, DISTAL CAP/ CASE CRACKED, IMAGE NOISY, PASSED DRY LEAK TEST, SUCTION TUBE RESISTANCE, SEGMENT STEEL BRAID CUT, CONNECTOR ROOT BRACE CRACKED, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, PASSED WET LEAK TEST, FLUID INVASION NOT OBSERVED IN CONTROL BODY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, UMBILICAL CABLE BUMP AT PVE SIDE, SEGMENT COMPRESSED. 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 PARTS, AND RETURNED TO THE USER UPON COMPLETION: O-RINGS AND SEALS, OPERATION CHANNEL, BENDING RUBBER, DISTAL CASE/CAP, STAYCOIL COLLAR, SEGMENT STAYCOIL ASSY IMP-C/PB-FREE, SUCTION CHANNEL LG, ROOT BRACE RUBBER LG CONNECTOR, PCB FOR CCD K2 PB-FREE/NTSC, ELECTRICAL CONNECTOR ASSY, O-RING(0.5X1.3) IMP-1, O-RING (1.8X19.8). MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 29-MAR-2013. THE ENDOSCOPE IS AWAITING REPAIR OR APPROVAL BY FINAL QC AS OF 06-MAY-2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682454 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK 04961333229611

    Patients

    Seq Age Sex Outcome Treatment
    1