BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 12285954 · Received August 6, 2021

    Report

    Report Number
    9610877-2021-10368
    Event Type
    Malfunction
    Date Received
    August 6, 2021
    Date of Event
    March 24, 2021
    Report Date
    August 6, 2021
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    ODG
    UDI-DI
    04961333233793
    PMA / PMN Number
    K182004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: IT WAS CAUSED DUE TO THE LIGHT GUIDE PLUG WORN OUT. IN ADDITION, WE CONFIRMED THAT LIGHT GUIDE CABLE BUCKLE, THE SUCTION CHANNEL BUCKLE, THE US CONNECTION CABLE BUCKLE, AND THE OPERATION CHANNEL PERFORATION, HOWEVER, THESE ARE NOT RELATED TO THE ALLEGED COMPLAINT. DETAIL OF CAPA (B)(4). ROOT CAUSE: THIN-FILM RESISTOR MANUFACTURED BY SUSUMU HAS LESS DURABILITY TO WET DIRT OR DUST, RESULTING IN ELECTRIC CORROSION. FOR THIS COMPONENT, THERE WAS NO DESIGN STANDARD TO SELECT THE COMPONENT. COUNTERMEASURE: AN INORGANIC PROTECTIVE FILM IS APPLIED TO THE PROTECTIVE COAT BY A CVD (CHEMICAL VAPOR DEPOSITION) METHOD TO IMPROVE ADHESION AND AIRTIGHTNESS, THEREBY PREVENTING DETERIORATION OF ADHESION DUE TO CORROSION AND PREVENTING FOREIGN MATTER IN THE RESISTANCE FILM. ALTERNATIVE USE OF RG SERIES TO PREVENT INTRUSION. IN THE RESISTANCE SWEAT RESISTANCE EVALUATION TEST OF THE MANUFACTURER, THE FAILURE RATE IS LOWER THAN THAT OF THE COMPANY'S PRODUCTS AND OTHER COMPANIES' PRODUCTS, AND THERE ARE NO CASES OF SIMILAR DEFECT REPORTS OF RESISTANCE PATTERN DISAPPEARANCE IN THE HIGHLY RELIABLE RG SERIES BY INQUIRING. CORRECTION: DESIGN CHANGE FOR THE RESISTOR CONCERNED OF EPK-3000. CORRECTIVE ACTION:DOCUMENT THIS ISSUE AS DESIGN STANDARD AND SHARE THE EVENT AND PROVIDE TRAINING FOR NPI PROCESSOR THAT IS NEWLY DESIGNED IN FUTURE. RISK ASSESSMENT RESULT: LOW EX-080-0007 PM-210030. ESTIMATED HAZARDOUS SITUATION:UNCLEAR/LOSS OF OBSERVATION IMAGES.*UNABLE TO CONTINUE THE ENDOSCOPY. OBJECTIVE: PATIENTS. OCCURRENCE: DURING HEMOSTASIS, "NUMBER OF CASES : (B)(4) CASES, NUMBER OF COMPLAINTS : (B)(4) COMPLAINTS, OCCURRENCE FREQUENCY :(B)(4)%". BASED ON THE ABOVE, IT IS JUDGED THAT THE PROBABILITY OF OCCURRENCE OF THE ESTIMATED HARM IS RARE AND RISK IS LOW. AS A RESULT OF RISK ASSESSMENT, NO FIELD CORRECTIVE ACTION IS PLANNED AT THIS MOMENT. PENTAX WILL CHANGE DESIGN PROCESS AND PROVIDE TRAINING FOR NPI PROCESS THAT IS NEWLY DESIGNED IN FUTURE. THIS REPORT IS BEING FILED AS PART OF THE PENTAX BACKLOG MANAGEMENT PLAN.

    Description of Event or Problem · 1

    THIS TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. LIGHT GUIDE PLUG CORRODED. THIS MODEL SHOULD BE COVERED BY (B)(4) ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184626 PENTAX LINEAR ULTRASOUND VIDEO GASTROSCOPE ODG HOYA CORPORATION PENTAX TOKYO OFFICE EG-3270UK 04961333233793

    Patients

    Seq Age Sex Outcome Treatment
    1