BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 10916027 · Received November 28, 2020

    Report

    Report Number
    9610877-2020-00244
    Event Type
    Malfunction
    Date Received
    November 28, 2020
    Date of Event
    October 28, 2020
    Report Date
    October 29, 2020
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K192245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 29-OCT-2020 THAT OCCURRED IN THE OPERATING ROOM DURING USE IN THE UNITED STATES. THE REPORTED COMPLAINT THAT WHILE A "ERCP[ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY WAS] BEING DONE IN THE OR WITH AN ENDOSCOPIST AND A SURGEON. WHEN THE ENDOSCOPIST TRIED PUTTING THE SCOPE THRU THE TROCAR IT GOT STUCK. WHEN THE SCOPE WAS REMOVED THE CAP HAD COME OFF INSIDE THE TROCAR. THIS WAS ATTEMPTED A SECOND TIME WITH THIS SAME PATIENT AND AFTER CHECKING TO SEE IF THE CAP WAS SECURE AND PLACED PROPERLY, IT CAME OFF AGAIN INSIDE THE TROCAR.", INVOLVING A PENTAX MEDICAL ACCESSORY MODEL OE-A63, LOT #0011040, USED WITH A PENTAX MEDICAL VIDEO DUODENOSCOPE, MODEL ED34-I10T2, UNKNOWN SERIAL NUMBER. THE TROCAR WAS REMOVED AND REPLACED. THE ENDOSCOPE SERIAL NUMBER WERE REQUESTED. THE COMPLAINT IS CURRENTLY UNDER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1380455 PENTAX STERILE DISTAL END CAP WITH ELEVATOR FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 0011040

    Patients

    Seq Age Sex Outcome Treatment
    1