BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX MEDICAL

    MDR report key: 24795921 · Received April 6, 2026

    Report

    Report Number
    9610877-2026-00018
    Event Type
    Injury
    Date Received
    April 6, 2026
    Date of Event
    February 12, 2026
    Report Date
    April 6, 2026
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    PMA / PMN Number
    K192245
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: CONTINUED: HEALTH EFFECT - CLINICAL CODE: 2687 FOREIGN BODY IN PATIENT, 1699 AIRWAY OBSTRUCTION. HEALTH EFFECT - IMPACT CODE: 4619 TEMPORARY IMPAIRMENT. MEDICAL DEVICE PROBLEM CODE: 2923 DEVICE DISLODGED OR DISLOCATED. COMPONENT CODE: 424 CAP. TYPE OF INVESTIGATION: 4118 TYPES OF INVESTIGATION NOT YET DETERMINED. INVESTIGATION FINDINGS: 3233 RESULTS PENDING COMPLETION OF INVESTIGATION. INVESTIGATION CONCLUSIONS: 11 CONCLUSIONS NOT YET AVAILABLE. PENTAX MEDICAL EMEA CONDUCTED A GOOD FAITH EFFORT (GFE) TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, AND RESPONSES WERE RECEIVED VIA EMAIL ON 17-MAR-2026. IT WAS REPORTED THAT AFTER THE ERCP PROCEDURE, THE PATIENT EXPERIENCED HYPOPHARYNGEAL DISCOMFORT A FEW HOURS LATER AND EXPELLED AN OBJECT FROM THE ORAL CAVITY, WHICH WAS IDENTIFIED AS THE DISPOSABLE ENDOSCOPIC CAP (DEC) OF THE DUODENOSCOPE. IT WAS ALSO REPORTED THAT THE DETACHMENT LIKELY OCCURRED DURING WITHDRAWAL OF THE DUODENOSCOPE WHILE PASSING THROUGH THE PHARYNX, AND THE CAP REMAINED IN THE HYPOPHARYNX. THE CAUSE OF THE DETACHMENT HAS NOT BEEN DETERMINED. THE INFORMATION CONFIRMED THAT THE PROCEDURE WAS COMPLETED, THE PATIENT WAS IN GOOD CONDITION, AND NO PATIENT HARM WAS REPORTED. IT WAS ALSO REPORTED THAT THE DETACHED DEC COULD NOT BE RETRIEVED AS THE PATIENT TOOK IT HOME. 9610877-2026-00017_ED34-I10T2_A110336_DETACHED STERILE CAP FELL INTO PATIENT _OE-A63_0021095_DETACHED STERILE CAP FELL INTO PATIENT.

    Description of Event or Problem · 0

    ON 12-MAR-2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP MODEL OE-A63, LOT NUMBER 0021095 IN SPAIN WITHIN THE EMEA REGION. DURING AN ERCP PROCEDURE, THE SINGLE-USE STERILE DISTAL END CAP DETACHED FROM THE ENDOSCOPE DURING WITHDRAWAL OF THE ENDOSCOPE. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY. HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848664 PENTAX MEDICAL SINGLE USE, STERILE DISTAL END CAP WITH ELEVATOR OE-A63 FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 0021095

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other