BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTAX MEDICAL

    MDR report key: 24142957 · Received January 22, 2026

    Report

    Report Number
    9610877-2026-00001
    Event Type
    Injury
    Date Received
    January 22, 2026
    Date of Event
    December 12, 2025
    Report Date
    March 13, 2026
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDT
    UDI-DI
    04961333232994
    PMA / PMN Number
    K192245
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO REPLACE A PREVIOUSLY SUBMITTED MDR THAT CONTAINED AN INCORRECT MANUFACTURER REPORT NUMBER. THE PREVIOUSLY SUBMITTED REPORT WAS ASSIGNED MFR REPORT NUMBER 9610877-2025-00222, WHICH WAS LATER DETERMINED TO BE INCORRECT. THIS REPORT IS SUBMITTED AS THE CORRECT INITIAL MDR WITH MFR REPORT NUMBER. NO OTHER INFORMATION HAS CHANGED. AT THIS TIME, PENTAX MEDICAL EMEA IS PERFORMING A GOOD FAITH EFFORT (GFE) TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT; HOWEVER, NO RESPONSE HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THE FOLLOWING INFORMATION HAS BEEN REQUESTED FROM THE FACILITY AND IS CURRENTLY PENDING: - INFORMATION REGARDING THE ENDOSCOPE USED IN CONJUNCTION WITH THE EVENT, INCLUDING MODEL NAME AND SERIAL NUMBER. - CLARIFICATION AS TO WHETHER THE DISTAL END CAP (DEC) DETACHED AND FELL OFF, OR WHETHER THE ALBARRAN LEVER BROKE AND DETACHED. IF THE DEC IS CONFIRMED TO HAVE DETACHED, THE FOLLOWING INFORMATION HAS BEEN REQUESTED: - WHETHER THE FACILITY WAS PROVIDED WITH THE LATEST INSTRUCTIONS FOR USE (IFU). - WHETHER THE PERSON WHO INSTALLED THE DEC WAS A TRAINED AND EXPERIENCED USER OR AN UNTRAINED USER. - WHETHER A CLICKING SOUND WAS HEARD DURING DEC INSTALLATION AND WHETHER THE DEC WAS PULLED AFTER INSTALLATION TO CONFIRM PROPER LOCKING. - THE SPECIFIC OPERATION OR MANEUVER THAT CAUSED THE DEC TO DETACH. - WHETHER THE ENDOSCOPE WAS RETURNED TO PENTAX MEDICAL FOR INSPECTION AND WHETHER ANY ABNORMALITIES WERE IDENTIFIED. - IF ABNORMALITIES WERE IDENTIFIED, PHOTOGRAPHIC DOCUMENTATION HAS BEEN REQUESTED. IF THE ALBARRAN LEVER IS CONFIRMED TO HAVE DETACHED, CLARIFICATION HAS BEEN REQUESTED REGARDING HOW IT WAS USED AND HOW SUCH USE MAY HAVE RESULTED IN DAMAGE TO THE DEC. INVESTIGATION IS IN PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION: B1: ADVERSE EVENT OR PRODUCT PROBLEM - "ADVERSE EVENT" TO "PRODUCT PROBLEM" B2: OUTCOMES ATTRIBUTED TO ADVERSE EVENT - DELETED. B4: DATE OF THIS REPORT - UPDATED. G1: CONTACT OFFICE - UPDATED. G6: FOLLOW-UP #: 1. H2: IF FOLLOW-UP, WHAT TYPE? - UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER - "NO" TO "YES" H6: CODES UPDATED - HEALTH EFFECT - CLINICAL CODE, HEALTH EFFECT - IMPACT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS-UPDATED. ADDITIONAL INFORMATION: D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI). D9: IS THIS DEVICE AVAILABLE FOR EVALUATION? EVALUATION SUMMARY: AS PART OF THE ONGOING INVESTIGATION, THE MANUFACTURER COLLABORATED WITH PENTAX MEDICAL EMEA AND CONDUCTED REPEATED GOOD FAITH EFFORTS (GFE) TO OBTAIN ADDITIONAL INFORMATION FROM THE USER FACILITY. ADDITIONAL CLARIFICATION WAS RECEIVED VIA EMAIL FROM THE USER FACILITY. IN THE INITIAL REPORT, IT WAS STATED THAT THE DETACHED DEC WAS RETRIEVED FROM THE PATIENT'S BODY AND THAT NO HARM OCCURRED. HOWEVER, BASED ON THE INFORMATION SUBSEQUENTLY OBTAINED FROM THE USER FACILITY, IT WAS CONFIRMED THAT THE DEC DID NOT DETACH INSIDE THE PATIENT'S BODY. ACCORDING TO THE USER FACILITY, DURING THE EXAMINATION IT WAS NOTICED THAT THE ALBARRAN LEVER COULD NO LONGER BE MOVED. THE ENDOSCOPE WAS THEN REMOVED FROM THE PATIENT AND THE DISTAL END WAS INSPECTED. AT THAT TIME, THE PHYSICIAN WAS HOLDING THE DISTAL CAP WITH THREE SEPARATED PARTS. THE USER FACILITY CONFIRMED THAT THE ALBARRAN LEVER ITSELF DID NOT FALL OFF. HOWEVER, AFTER REMOVAL OF THE ENDOSCOPE, THE DISTAL CAP ASSEMBLY WAS FOUND SEPARATED INTO THREE COMPONENTS. THE FACILITY ALSO CONFIRMED THAT THE DEC HAD BEEN INSTALLED BY A TRAINED AND EXPERIENCED USER, THAT A CLICK WAS HEARD DURING INSTALLATION, AND THAT THE DEC WAS PULLED TO VERIFY THAT IT WAS LOCKED. BASED ON THE INFORMATION OBTAINED DURING THE INVESTIGATION, THE EXACT CIRCUMSTANCES THAT LED TO THE MALFUNCTION COULD NOT BE DETERMINED. THE USER FACILITY WAS UNABLE TO PROVIDE INFORMATION REGARDING THE SPECIFIC PROCEDURE OR TREATMENT DEVICES USED DURING THE EXAMINATION. HOWEVER, IT IS POSSIBLE THAT THE FIXATION OF THE DEC BECAME LOOSE DURING THE PROCEDURE. NO PATIENT HARM HAS BEEN REPORTED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THAT THE DEVICE WAS MANUFACTURED AND COMPLETED UNDER NORMAL CONDITIONS ON 09-DEC-2024, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. THERE WERE NO REWORKS OR CONCESSIONS, AND THE DATES OF APPROVAL FOR SHIPMENT AND THE ACTUAL DATE SHIPPED WERE CONFIRMED AS 20-DEC-2024. BASED ON THE TREND ANALYSIS, THERE IS NO SIGNIFICANT INCREASE OR UPWARD TREND IN REPAIR COMPLAINTS RELATED TO THIS FAILURE MODE OR HAZARD. PENTAX MEDICAL HAS NOT RECEIVED ANY FURTHER INFORMATION FOR THIS EVENT AND THEREFORE CONSIDERS THIS MEDWATCH REPORT CLOSED.

    Description of Event or Problem · 0

    ON 12-DEC-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL STERILE DISTAL END CAP, LOT NUMBER 0021124 IN GERMANY WITHIN THE EMEA REGION. DURING A DUODENOSCOPY, A SINGLE-USE STERILE DISTAL END CAP (DEC) CAME OFF AND FELL INTO THE PATIENT'S BODY. THE DETACHED DEC WAS RETRIEVED FROM THE PATIENT'S BODY, AND NO HARM OCCURRED. 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
    203222 PENTAX MEDICAL STERILE DISTAL END CAP FDT HOYA CORPORATION PENTAX TOKYO OFFICE OE-A63 0021124 04961333232994

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention