BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9216391 · Received October 21, 2019

    Report

    Report Number
    9610877-2019-01486
    Event Type
    Malfunction
    Date Received
    October 21, 2019
    Report Date
    September 23, 2019
    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
    MI, 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 CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 19-SEP-2019 AND INSPECTION OF THE UNIT WAS PERFORMED ON 23-SEP-2019 WHERE THE QUALITY CONTROL INSPECTOR FOUND THE FOLLOWING: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, OPERATION CHANNEL- PRIMARY SLICE BY ACCESSORY, DISTAL CAP/ CASE CRACKED, DISTAL TIP ANNUAL MAINTENANCE, PASSED DRY LEAK TEST, INSERTION TUBE ROOT BRACE CRACKED, LIGHTGUIDE PRONG COVER GLASS SET LOOSE, PASSED WET LEAK TEST, ELEVATOR BODY STICKING, FLUID INVASION NOT OBSERVED IN CONTROL BODY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE. THE DUODENOSCOPE'S REPAIRS WILL INCLUDE THE DISTAL CASE/CAP, WHICH WILL BE REPLACED AND/OR RESEALED PURSUANT TO THE FIELD CORRECTION, ALONG WITH MISCELLANEOUS PARTS, AND RETURNED TO THE USER UPON COMPLETION. THE DUODENOSCOPE WAS REPAIRED INCLUDING THE FOLLOWING COMPONENTS AND APPROVED BY FINAL QC ON 07-OCT-2019: AIR/WATER TUBE, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, OPERATION CHANNEL, BENDING RUBBER, LIGHT GUIDE CABLE, ROOT BRACE RUBBER, REMOTE CONTROL BUTTON, O-RINGS AND SEALS, RL LOCK KNOB, BODY SIDE COVER FOR DEFLECTOR, INSERTION TUBE ATTACHING NUT IMP-1, ROOT BRACE RUBBER, AIR/WATER SUPPLY TUBE LG, SUCTION CHANNEL LG, DISTAL CASE/CAP. THE DUODENOSCOPE WAS DELIVERED TO THE CUSTOMER ON 07-OCT-2019 UNDER DELIVERY ORDER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009625 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK

    Patients

    Seq Age Sex Outcome Treatment
    1