PENTAX EG-3270UKRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 04961333233793), received between Aug 6, 2021 and Aug 5, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50137434 ↗
• MalfunctionJun 18, 2026Optical Obstruction

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25542254 ↗
• MalfunctionMay 12, 2026Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25146011 ↗
• MalfunctionJun 25, 2025Optical Obstruction; Optical Obstruction

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22325453 ↗
• MalfunctionOct 31, 2024Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20575833 ↗
• MalfunctionSep 24, 2024Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20289348 ↗
• MalfunctionMar 8, 2022Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691881 ↗
• MalfunctionDec 8, 2021Unintended Movement; Unintended Movement

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12958451 ↗
• MalfunctionAug 26, 2021Obstruction of Flow; Obstruction of Flow

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT THAT OCCURRED IN THE UNITED STATES. THE INFORMATION PROVIDED INDICATED THAT THE SUCTION CHANNEL WAS BLOCKED INVOLVING A PENTAX MEDICAL ULTRASOUND VIDEO GASTROSCOPE MODEL EG-3270UK, SERIAL NUMBER (B)(4). THE CUSTOMER STATED THERE WAS AN INTERNAL LEAK INSIDE THE CHANNEL. GOOD FAITH EFFORTS(GFE) EMAILS HAVE BEEN SENT. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE CUSTOMER OWNED ENDOSCOPE WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 02-AUG-2021. THE ENDOSCOPE WAS INSPECTED BY PENTAX MEDICAL SERVICE UNDER SERVICE ORDER (B)(4) AND DURING QUALITY INSPECTION THE TECHNICIAN CONFIRMED THE CUSTOMERS EXPERIENCE AS THE "OPERATION CHANNEL- PRIMARY SLICE BY ACCESSORY" WAS IDENTIFIED AND ALSO DOCUMENTED THE FOLLOWING INSPECTION FINDINGS: LEAK AT BIOPSY CHANNEL (LARGE/ PRIMARY) DISTAL SIDE, FAILED WET LEAK TEST, FAILED DRY LEAK TEST, SUCTION TUBE MILD RESISTANCE, ULTRASOUND WARNING LABEL CUT, SUCTION FUNCTION NOT PERFORMED UNIT COMPROMISED, OPERATION CHANNEL- PRIMARY SLICE BY ACCESSORY, FLUID INVASION NOT OBSERVED IN PVE CONNECTOR, FLUID INVASION NOT OBSERVED IN CONTROL BODY. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: O-RINGS AN

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12373950 ↗
• MalfunctionAug 6, 2021Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn

  THIS TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. LIGHT GUIDE PLUG CORRODED. THIS MODEL SHOULD BE COVERED BY (B)(4) ALSO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12285954 ↗