BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTAX

    MDR report key: 25055057 · Received May 1, 2026

    Report

    Report Number
    9610877-2026-00022
    Event Type
    Malfunction
    Date Received
    May 1, 2026
    Date of Event
    April 7, 2026
    Report Date
    May 1, 2026
    Manufacturer
    HOYA CORPORATION PENTAX TOKYO OFFICE
    Product Code
    FDF
    PMA / PMN Number
    K241213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS THAT THE ENDOSCOPIC IMAGE BECAME GRAINY AND REDDISH WHEN THE ENDOSCOPE REACHED THE CECUM DURING A COLONOSCOPIC PROCEDURE. THE PROCEDURE TIME WAS EXTENDED AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT ENDOSCOPE. PENTAX MEDICAL EMEA PERFORMED GFE TO GATHER ADDITIONAL INFORMATION REGARDING THIS EVENT AND RECEIVED RESPONSES TO ITS INQUIRIES VIA EMAIL ON 14-APR-2026. ACCORDING TO INFORMATION OBTAINED FROM THE USER FACILITY, NO ACTIVE BLEEDING WAS OBSERVED PRIOR TO REACHING THE CECUM. DEBRIS WAS OBSERVED ADHERING AND COAGULATING ON THE ILLUMINATION LENS AT THE DISTAL END OF THE ENDOSCOPE AFTER WITHDRAWAL, AND THE DISTAL END WAS FOUND TO BE HOT. IT WAS ALSO REPORTED THAT LIGHT LIMIT MODE (LLM) WAS NOT USED DURING THE PROCEDURE. THE PROCESSOR USED DURING THE PROCEDURE WAS EPK-I8020C (SERIAL NUMBER (B)(6) WITH SOFTWARE VERSION 0107C-1.0060. THE AVAILABILITY OF THE DEVICE FOR EVALUATION IS CURRENTLY UNKNOWN. INVESTIGATION IS IN PROCESS. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED WITH THE NEW INFORMATION.

    Description of Event or Problem · 0

    ON 10-APR-2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO COLONOSCOPE MODEL EC34-I20CL, SERIAL NUMBER (B)(6) IN IRELAND WITHIN THE EMEA REGION. DURING A COLONOSCOPIC PROCEDURE, WHEN THE ENDOSCOPE REACHED THE CAECUM, THE ENDOSCOPIC IMAGE BECAME GRAINY AND REDDISH. WHEN THE ENDOSCOPE WAS WITHDRAWN FROM THE PATIENT, THE DISTAL END OF THE ENDOSCOPE WAS FOUND TO BE HOT, AND WASTE MATTER HAD ADHERED AND COAGULATED ON THE ILLUMINATION LENS AT THE DISTAL END. THE PHYSICIAN PERFORMED A BIOPSY ON AN AREA CONSIDERED TO BE A SUSPICIOUS LESION DUE TO THE DETERIORATION IN IMAGE QUALITY, HOWEVER THE AREA WAS IDENTIFIED AS FECAL MATTER. THE PROCEDURE WAS COMPLETED USING A REPLACEMENT ENDOSCOPE, BUT THE PROCEDURE TIME WAS EXTENDED. THE PHYSICIAN REPORTED THAT THE DETERIORATION OF THE ENDOSCOPIC IMAGE INTERFERED WITH THE PROCEDURE AND THAT THE ENDOSCOPE WAS NOT USED FOR THE REMAINING PROCEDURES ON THAT DAY. THERE WAS NO REPORT OF PATIENT HARM. 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
    176665 PENTAX PENTAX MEDICAL VIDEO COLONOSCOPE EC34-I20C SERIES FDF HOYA CORPORATION PENTAX TOKYO OFFICE EC34-I20CL A003EA0269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female