BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 9889212 · Received March 27, 2020

    Report

    Report Number
    9610877-2020-00046
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Date of Event
    February 28, 2020
    Report Date
    March 3, 2020
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K192245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYMPTOM "DEPENDING THE ANGULATION APPLIED ON THE BENDING SECTION OF THE ED34-I10T2 #A110240, THE ELEVATOR DOESN'T RETURN TO THE NEUTRAL POSITION. WHEN THE INSERTION FLEXIBLE TUBE IS STRAIGHT THE ELEVATOR SEEMS TO WORK NORMALLY." IS A NORMAL BEHAVIOR OF THE ELEVATOR DUE TO BECOMING SHORTER OF THE LENGTH OF ELEVATOR WIRE UNDER THE BENDING CONDITION. THOUGH THE ELEVATOR IS RAISED DURING THE ANGULATION APPLIED ON THE BENDING SECTION, IT WILL BE BACK TO THE NORMAL POSITION WITH PASSING THE ACCESSARY. EVENT PROBLEM AND EVALUATION CODES: PATIENT CODES: (B)(4) NO PATIENT INVOLVEMENT, DEVICE CODES: (B)(4) LOOSE OR INTERMITTENT CONNECTION,

    Description of Event or Problem · 1

    PENTAX MEDICAL BECAME AWARE OF A REPORT ON 03MAR2020 STATING, "IT'S IMPOSSIBLE TO SLIDE THE GUIDE WIRE. WHEN THE TIP WAS REMOVED, IT WAS DETACHED INTO TWO PARTS." INVOLVING PENTAX MEDICAL SINGLE USE DISTAL END CAP WITH ELEVATOR, MODEL OE-A63, LOT NUMBER 0021108. WITHOUT CONSIDERING ACCESSORIES, PENTAX FRANCE MOBILE TECHNICIAN AND PHYSICIAN PERFORMED SEVERAL TESTS WITH A OE-A63: HE WROTE THAT THERE IS NOT CLICK FELT DURING INSTALLATION OF THE DISPOSABLE END CAP AND FOLLOWING PHYSICIAN COMMENTS, THE ISSUE APPEARS WITH A RATE OF 1 FOR 3 AROUND. DEPENDING THE ANGULATION APPLIED ON THE BENDING SECTION OF THE ED34-I10T2 #: (B)(4), THE ELEVATOR DOESN'T RETURN TO THE NEUTRAL POSITION. WHEN THE INSERTION FLEXIBLE TUBE IS STRAIGHT THE ELEVATOR SEEMS TO WORK NORMALLY. THE ED34-I10T2 #: (B)(4) WILL BE SENT TO PENTAX (B)(4) FOR INVESTIGATION ON THE ELEVATOR ITSELF AND ON THE CONNECTION OF THE OE-A63 WITH OR WITHOUT "CLICK". PENTAX (B)(4) MENTION THAT THE COMPLAINT MIGHT BE RELATED TO PE18-0090 / EMEA-19-100083 AND PE20-0021 / EMEA-20-020019 AND EMEA-20-030008. POOR ATTACHMENT OF OE-A63 DISTAL END CAP, BUT IT IS NOT CONFIRMED. RETRAINING OF THE CLINIC PERSONAL RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351521 PENTAX SINGLE USE DISTAL END CAP WITH ELEVATOR FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 0021108

    Patients

    Seq Age Sex Outcome Treatment
    1