BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX

    MDR report key: 10652905 · Received October 8, 2020

    Report

    Report Number
    2518897-2020-00166
    Event Type
    Injury
    Date Received
    October 8, 2020
    Date of Event
    September 8, 2020
    Report Date
    December 7, 2022
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333240135
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    F7 UPDATED: FOLLOW UP #01 EVALUATION SUMMARY: THE FAILURE WAS DETERMINED TO BE CAUSED BY IMPROPER MOUNTING OF OE-A63 AND ED34-I10T2. ALSO, S FIELD ACTION WAS CARRIED OUT AND INSTRUCTIONS FOR USE(IFU) WERE DISTRIBUTED. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE, CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 1

    PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED IN THE OPERATING ROOM DURING USE IN (B)(6). THE REPORTED COMPLAINT RECEIVED ON 08-SEP-2020 STATED THAT THE USER FACILITY USED A PENTAX MEDICAL DEMO VIDEO DUODENOSCOPE, MODEL ED34-I10T2 - SERIAL NUMBER (B)(4), AT THE USER FACILITY FOR AN EMERGENCY ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY(ERCP) WITHOUT A PENTAX MEDICAL REPRESENTATIVE ON SITE. DURING THE ERCP, THE FACILITY MISTAKENLY USED A CAP INTENDED FOR USE WITH THE FACILITIES MODEL ED34-I10T ENDOSCOPE ON THE PENTAX MEDICAL VIDEO DUODENOSCOPE MODEL ED34-I10T2 ENDOSCOPE. THE FACILITY USED A T SCOPE CAP, MODEL OE-A55, INSTEAD OF THE DISPOSABLE STERILE DISTAL END CAP, MODEL OE-A63. AS A RESULT, THE OE-A55 WITH AN UNKNOWN LOT NUMBER, FELL OFF WITHIN THE PATIENT. NO RETRIEVAL WAS PERFORMED DURING THE PROCEDURE. THE PHYSICIAN MADE THE DECISION TO LET THE CAP PASS NATURALLY. ONCE THE CAP PASSES, IT WILL BE DISCARDED BY THE PATIENT, SO WILL BE UNAVAILABLE FOR EVALUATION. THE FACILITY IS REMOVING THE ED34-I10T2 SCOPE FROM THE FLEET TO ENSURE THAT THIS DOES NOT HAPPEN AGAIN. NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME OF REPORTING. PENTAX (B)(4) INC.(PCI) PROVIDED AN UPDATE ON 23-SEP-2020 VIA EMAIL PROVIDING THE PENTAX MEDICAL VIDEO DUODENOSCOPE SERIAL NUMBER FOR THE ED34-I10T2 AND THEY ALSO PROVIDED AN UPDATE FOR THE PATIENT STATUS STATING THE PATIENT IS GOOD AND IS AWARE OF THE CAP THAT WAS LOST. THE DEMO VIDEO DUODENOSCOPE WAS RETURNED TO PCI ON 05-OCT-2020 FOR EVALUATION. FINDINGS INCLUDED A MINOR COVER GLASS CHIP DOCUMENTED AS WEAR AND TEAR. PENTAX MODEL ED34-I10T2, SERIAL NUMBER A110425, HAS BEEN ROUTINELY SERVICED AT A PENTAX FACILITY AS A DEMO DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113895 PENTAX VIDEO DUODENOSCOPE FDT HOYA CORPORATION PENTAX TOKYO OFFICE ED34-I10T2 04961333240135

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other