BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 13009027 · Received December 15, 2021

    Report

    Report Number
    9610877-2021-01709
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    November 19, 2021
    Report Date
    December 15, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333129492
    PMA / PMN Number
    K131855
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO PENTAX FOR FURTHER EVALUATION ON SERVICE ORDER (B)(4) WHERE THE USER NARRATIVE WAS CONFIRMED. INSPECTION FINDINGS ARE AS FOLLOWS: IMAGE BLACKOUT, FLUID INVASION IN CONTROL BODY, DISTAL BODY CHIP AT CHANNEL OPENING AT THINNEST PART, INSERTION TUBE SEVERE DISCOLORATION AT STAGE 1, PVE ELECTRICAL PIN CORRODED, CONTROL BODY GRIP SCRATCHED, CONTROL BODY SEVERE CORROSION INSIDE, FLUID INVASION IN SEGMENT SECTION, PRIMARY OPERATION CHANNEL CRIMPED AT BIOPSY INLET T-PIE, DISTAL BODY ABRASION, ENDOSCOPE FAILED ELECTRICAL SAFETY TEST - PLCT FAILED WET LEAK TEST, LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) INLET SIDE, FAILED DRY LEAK TEST, RIGHT/ LEFT PULLEY WIRE FRAYED, PVE ELECTRICAL CONNECTOR FRAME MILD CORROSION, SEGMENT CORRODED, FLUID INVASION IN PVE CONNECTOR, PVE CONNECTOR HOUSING SCRATCHED, FLUID INVASION TO INSERTION TUBE, CUSTOMER COMPLAINT CONFIRMED, UP/ DOWN PULLEY WIRE FRAYED, CCD CIRCUIT BOARD CORROSION, CHEMICAL RESIDUE BUILDUP ON CONTROL BODY, RIGHT/ LEFT CONTROL KNOB SEVERE DISCOLORATION, FLUID DAMAGE TO LIGHT CARRYING BUNDLE, FLUID INVASION IN UMBILICAL LIGHT GUIDE CABLE, UP/ DOWN CONTROL KNOB/ LEVER SEVERE DISCOLORATION, HOLE IN # 2 REMOTE CONTROL BUTTON COVER, ZOOM LEVER TOUCHES RC BUTTON #3 WHEN USE, IMAGE BLACKOUT THE DEVICE IS IN THE PROCESS OF BEING REPAIR WHERE ALL DEFECTS FOUND WILL BE REMEDIATED AND RETURNED TO THE USER UPON COMPLETION. ON 24-NOV-2021, A DEVICE HISTORY RECORD (DHR) REVIEW FOR MODEL EG-2990I, SERIAL NUMBER (B)(4) WAS PERFORMED AND THE DHR REVIEW CONFIRMED THE ENDOSCOPE WAS MANUFACTURED ON 17-JAN-2008 AND HAD 1 FAILURE FOUND DURING IN-PROCESS INSPECTION FOR WATER LEAK. THE DEVICE WAS REWORKED WHERE THE K-PIPE WAS RECONNECTED. THE DEVICE PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. THE DATES OF APPROVAL FOR SHIPMENT AND ACTUAL DATE SHIPPED WERE CONFIRMED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN THE (B)(6) INVOLVING PENTAX VIDEO SCOPE EG-2990I. IN THE EVENT REPORTED, THE USER STATES THERE WAS NO VIDEO IMAGE. THE TIMING IS IN THE PROCEDURE ROOM BEFORE USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO OTHER INFORMATION PROVIDED WITH THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1906010 PENTAX VIDEO GASTROSCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2990I 04961333129492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown