BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9634046 · Received January 27, 2020

    Report

    Report Number
    9610877-2020-00030
    Event Type
    Malfunction
    Date Received
    January 27, 2020
    Report Date
    January 13, 2020
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K161222
    Removal / Correction Number
    NOT ISSUED YET
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON DISCUSSION WITH FDA ON MAY 8, 2017, ALL INSPECTIONAL FAILURES ARE BEING REPORTED AS MDRS NOTWITHSTANDING THE FACT THAT THE PRESENCE OF DISCONTINUITIES, GAPS OR BUBBLES DOES NOT NECESSARILY HAVE EITHER TECHNICAL OR CLINICAL SIGNIFICANCE. (B)(4).

    Description of Event or Problem · 1

    THE LOANER DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 19-JUL-2019 AND INSPECTION OF THE UNIT WAS PERFORMED ON 14-AUG-2020 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: INSERTION TUBE BUMP AT END OF ROOT BRACE, BIOPSY INSULATION RING DEFORMED, DISTAL CAP/ CASE CRACKED, PRISM SCRATCHED, HOLE IN # 4 REMOTE CONTROL BUTTON COVER, DISTAL CAP - FIXED TYPE PASSED EPOXY SEAL INTEGRITY INSPECTION, ETO VENT VALVE LOOSE INNER SHAFT, SEGMENT STEEL BRAID CUT, FAILED WET LEAK TEST, INSERTION TUBE ROOT BRACE BROKEN, FAILED DRY LEAK TEST, LIGHTGUIDE PRONG COVER GLASS SET SCRATCHED, PRISM LENS CHIPPED, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE, LEAK AT AIR/ WATER NOZZLE. ADDITION INSPECTION FINDINGS FROM 03-DEC-2019: WATER SUPPLY TUBE SHORT, AIR SUPPLY TUBE SHORT, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE. ADDITION INSPECTION FINDINGS FROM 13-JAN-2020: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, CHANNEL IMPROPERLY INSTALLED (GAP DISTAL BODY OPENING), DISTAL CAP - FIXED TYPE PASSED SEAL INTEGRITY INSPECTION. 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: AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, OPERATION CHANNEL, BENDING RUBBER, DISTAL CASE/CAP, INSERTION FLEXIBLE TUBE, STAYCOIL COLLAR, SEGMENT STAYCOIL ASSY IMP-C/PB-FREE, ROOT BRACE RUBBER, INSULATION RING ASSY, REMOTE CONTROL BUTTON, EOG VALVE ASSY, OBJECTIVE PRISM ASSY, AIR/WATER SUPPLY TUBE LG. THE VIDEO DUODENOSCOPE IS CURRENTLY AWAITING REPAIRS AND QC FINAL APPROVAL AS OF 27-JAN-2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96755 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1