BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 24695837 · Received March 26, 2026

    Report

    Report Number
    9610877-2026-00016
    Event Type
    Malfunction
    Date Received
    March 26, 2026
    Date of Event
    March 3, 2026
    Report Date
    May 22, 2026
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDS
    UDI-DI
    04961333234592
    PMA / PMN Number
    K251256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENTAX MEDICAL CONDUCTED A GOOD FAITH EFFORT (GFE) TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT, AND RESPONSES WERE RECEIVED VIA EMAIL FROM THE APAC REGION ON 24-MAR-2026. THE BLACK POWDER WAS SUGGESTED TO BE A LUBRICANT USED FOR ENDOSCOPES; HOWEVER, THIS IDENTIFICATION WAS BASED ONLY ON AN INQUIRY TO THE FSE AND WAS NOT DIRECTLY CONFIRMED. SEVERAL REQUESTED DETAILS, INCLUDING THE ORIGIN OF THE MATERIAL AND PATIENT-RELATED INFORMATION, WERE NOT PROVIDED. ACCORDING TO THE ACUTE ORAL TOXICITY TEST OF THE LUBRICANT, THE LD50 VALUE IS GREATER THAN 2,000 MG/KG BODY WEIGHT. BASED ON THIS INFORMATION, NO SIGNIFICANT HEALTH RISK IS EXPECTED FROM A SMALL AMOUNT OF EXPOSURE. THE INSPECTION TEAM AT PENTAX MEDICAL KOREA REPORTED THAT A LEAK IN THE BENDING RUBBER AND FLUID INGRESS INTO THE DISTAL SEGMENT WERE OBSERVED. THE DAMAGE TO THE BENDING RUBBER WAS IDENTIFIED, ALONG WITH THE LEAK AND FLUID INGRESS INTO THE DISTAL SEGMENT. 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 B4: DATE OF THIS REPORT - UPDATED. G6: FOLLOW-UP #: 1. H2: IF FOLLOW-UP, WHAT TYPE? - UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER - "NO" TO "YES". H6: CODES UPDATED - TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS - UPDATED. ADDITIONAL INFORMATION D4: PRIMARY UNIQUE DEVICE IDENTIFIER (UDI). H4: DEVICE MANUFACTURE DATE. H11: EVALUATION SUMMARY. EVALUATION SUMMARY THE REPORTED EVENT WAS THAT BLACK POWDER WAS FOUND INSIDE THE PATIENT DURING A PROCEDURE. NO PATIENT HARM HAS BEEN REPORTED TO DATE. BASED ON THE REPAIR INSPECTION RESULTS, A HOLE WAS IDENTIFIED IN THE COATED RUBBER, WHICH MAY HAVE ALLOWED ANTI-FRICTION MATERIAL TO LEAK FROM THE BENDING SECTION. IT WAS ALSO CONSIDERED THAT THE ANTI-FRICTION MATERIAL LEAKED FROM THE HOLE IN THE COATED RUBBER DURING THE PROCEDURE BECAUSE A LEAK TEST WAS NOT PERFORMED BEFORE USE. THE DEVICE WILL BE REPAIRED BY REPLACEMENT OF THE SUCTION CHANNEL, BENDING RUBBER, SEGMENT STAYCOIL ASSEMBLY, LIGHT CABLE BUNDLE (LCB), LCB DISTAL COVER GLASS, AND CCD-M WITH DRIVE PCB. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED BY THE MANUFACTURER. THE DHR REVIEW CONFIRMED THAT THE ENDOSCOPE WAS MANUFACTURED AT MIYAGI ON 28-JUN-2024 UNDER NORMAL CONDITIONS, PASSED ALL REQUIRED INSPECTIONS, AND WAS RELEASED ACCORDINGLY. ALSO, THERE WERE NO REWORKS OR CONCESSIONS, AND THE ACTUAL DATE SHIPPED WAS CONFIRMED AS 05-JUL-2024. BASED ON THE TREND ANALYSIS, NO SIGNIFICANT INCREASE OR UPWARD TREND IN REPAIR COMPLAINTS RELATED TO THIS FAILURE MODE WAS IDENTIFIED. 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 03-MAR-2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG27-I10, SERIAL NUMBER (B)(6) IN KOREA WITHIN THE APAC REGION. DURING AN ENDOSCOPIC PROCEDURE, BLACK POWDER-LIKE MATERIAL WAS FOUND INSIDE THE PATIENT. IT WAS REPORTED THAT THE ENDOSCOPE HAD BEEN USED WITHOUT CONDUCTING THE REQUIRED LEAK TEST. THE OPERATOR IMMEDIATELY IRRIGATED THE AREA USING A SYRINGE, PERFORMED WASHING AND SUCTION, AND COMPLETED BASIC CLEANING. THERE WAS NO REPORT OF PATIENT HARM, ALTHOUGH CONCERN REGARDING POTENTIAL LONG-TERM EFFECTS WAS EXPRESSED. 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
    150535 PENTAX VIDEO UPPER G.I.SCOPE FDS HOYA CORPORATION PENTAX TOKYO OFFICE EG27-I10 04961333234592

    Patients

    Seq Age Sex Outcome Treatment
    1