PENTAX Medical EG27-i20cRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04961333254644), received between Nov 18, 2025 and Jan 27, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Fluid/Blood Leak; Material Protrusion/Extrusion

  ON 15-DEC-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO GASTROSCOPE MODEL EG27-I20C SERIAL NUMBER (B)(6) IN KOREA WITHIN THE APAC REGION. AFTER THE ENDOSCOPE WAS RETURNED TO THE CUSTOMER FOLLOWING REPAIR, THE ENDOSCOPE FAILED A LEAK TEST DURING REPROCESSING. THE ENDOSCOPE HAD PASSED THE FINAL QUALITY INSPECTION AFTER THE REPAIR. WHEN THE ENDOSCOPE WAS INSPECTED, A LEAK FROM THE JET TUBE WAS IDENTIFIED AND THE BRAID, WHICH IS A METAL MESH, WAS FOUND PROTRUDING FROM THE INSERTION FLEXIBLE TUBE. THERE WAS NO REPORT OF PATIENT HARM. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT OCCURRED DURING REPROCESSING. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24186840 ↗
• MalfunctionNov 18, 2025No Display/Image; No Display/Image

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (BLACKOUT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23578307 ↗