BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 11355498 · Received February 19, 2021

    Report

    Report Number
    9610877-2021-00050
    Event Type
    Malfunction
    Date Received
    February 19, 2021
    Report Date
    January 13, 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
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF) ADVERSE EVENT REPORTING. NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. NO HEALTH CONSEQUENCES OR IMPACT. LOSS OR FAILURE TO BOND. COMPONENT CODE: 424 CAP. TYPE OF INVESTIGATION: 10 TESTING OF ACTUAL/SUSPECTED DEVICE. INVESTIGATION FINDINGS: 140 WEAR PROBLEM. INVESTIGATION CONCLUSIONS: 19 CAUSE TRACED TO USER.

    Description of Event or Problem · 1

    THE CUSTOMER OWNED DEVICE WAS PREVIOUSLY RETURNED TO PENTAX MEDICAL FROM A CUSTOMER ON 12-JAN-2021 AND INSPECTION OF THE UNIT WAS PERFORMED UNDER SERVICE ORDER 3130940 WHERE THE QUALITY CONTROL INSPECTOR DOCUMENTED THE FOLLOWING CODES ON 13-JAN-2021: DISTAL CAP - FIXED TYPE FAILED EPOXY SEAL INTEGRITY INSPECTION, LIGHT CARRYING BUNDLE BUNDLE HAS LESS THAN 70% TRANSMISSION, DISTAL CAP/ CASE CRACKED, PRIMARY OPERATION CHANNEL RESISTANCE, RIGHT/ LEFT BRAKE KNOB MARKINGS FADED, AIR/ WATER SOCKET CYLINDER O-RING CHIPPED, DISTAL TIP ANNUAL MAINTENANCE, PASSED DRY LEAK TEST, SUCTION TUBE RESISTANCE, SEGMENT STEEL BRAID CUT, PASSED WET LEAK TEST, MIDDLE LCB DISTAL COVER GLASS GLUE IS MISSING, IMAGE DARK, FLUID INVASION NOT OBSERVED IN CONTROL BODY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, UMBILICAL CABLE SINGLE BUCKLED UNDER PVE ROOT BRACE, 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, AIR/WATER TUBE, DEFLECTOR BODY ATTACHING SCREW, DEFLECTOR OPERATING WIRE, DEFLECTOR STAYCOIL, LCB DISTAL COVER, LIGHT GUIDE FIBER BUNDLE (LCB), OPERATION CHANNEL, ADJUSTING COLLAR, ANGLE WIRE, BENDING RUBBER, DISTAL CASE/CAP, RL PULLEY ASSY, UD PULLEY ASSY, SUCTION CHANNEL LG, O-RING(0.5X1.3) IMP-1, BODY SIDE COVER FOR DEFLECTOR, DEFLECTOR BODY, DEFLECTOR BODY ATTACHING SCREW, DEFLECTOR BODY LINK, COLORED RING BLACK, FWD BODY TRIM COLLAR, FWD BODY TRIM COVER ATTACHING NUT, RUBBER TRIM COLLAR. MODEL ED-3490TK, SERIAL NUMBER (B)(4), HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY SINCE THE DEVICE WAS PUT INTO SERVICE ON 29-APR-2010. THE ENDOSCOPE WAS DELIVERED TO THE CUSTOMER ON 04-FEB-2021 UNDER DELIVERY ORDER 82136880.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250674 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED-3490TK 04961333229611

    Patients

    Seq Age Sex Outcome Treatment
    1