BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 16730052 · Received April 13, 2023

    Report

    Report Number
    9610877-2023-53441
    Event Type
    Malfunction
    Date Received
    April 13, 2023
    Date of Event
    March 25, 2023
    Report Date
    April 13, 2023
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333129492
    PMA / PMN Number
    K131902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS RETURNED TO PENTAX MEDICAL FOR REPAIR. OUR TECHNICIAN CHECKED THE RETURNED UNIT AND CONFIRMED THAT THE CCD MODULE WITH DRIVE PCB BLACKOUT. BASED ON THE RESULT, WE CONCLUDED THAT IT WAS CAUSED DUE TO THE EXCESSIVE FORCE APPLIED ON THE CCD MODULE WITH DRIVE PCB. IN ADDITION, OUR TECHNICIAN CONFIRMED THAT THE INSERTION FLEXIBLE TUBE FLUID DAMAGE, THE SEGMENT FLUID DAMAGE, THE CONTROL BODY FLUID DAMAGE, THE CCD MODULE WITH DRIVE PCB FLUID DAMAGE, THE LCB (LIGHT CARRYING BUNDLE) FLUID DAMAGE, THE LIGHT GUIDE CABLE FLUID DAMAGE, THE LG CONNECTOR FLUID DAMAGE, THE LCB (LIGHT CARRYING BUNDLE) BROKEN, THE LG CABLE CONNECTOR HOUSING BROKEN, THE INSERTION FLEXIBLE TUBE BUCKLED, THE ROOT BRACE RUBBER (LG CONNECTOR) CRACKED, THE ROOT BRACE RUBBER LG PRONG CRACKED, THE SEGMENT CORRODED, THE CCD DRIVE PCB CORRODED, THE LG CONNECTOR CORRODED, THE OPERATION CHANNEL (PRIMARY) LEAK, THE OPERATION CHANNEL (PRIMARY) CUT, THE LG WATER SUPPLY TUBES CUT, THE LG WATER JET SUPPLY TUBES CUT, THE LG AIR SUPPLY TUBES CUT, THE SUCTION CHANNEL DIRTY, THE REMOTE CONTROL BUTTONS DISINFECTIONS DAMAGE, AND THE DISTAL BODY WORN OUT; HOWEVER, THESE DEFECTS ARE NOT THE MAIN CAUSE, AND/OR IRRELEVANT TO THE ALLEGED COMPLAINT. BASED ON THE TECHNICAL REPORT ""HR-RPT-0586(IMAGE FAILURE)"" AND/OR THE RISK ANALYSIS RESULTS, IT WAS EVALUATED TO SUBMIT MDR.

    Description of Event or Problem · 0

    THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478994 PENTAX HD VIDEO GASTROSCOPE 2.8C 9.8T 1050L FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG-2990I 04961333129492

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown