PENTAX Medical EC34-i10cL (UDI 04961333248711)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04961333248711), received between Jul 15, 2021 and Jan 16, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Optical Distortion” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Erratic or Intermittent Display

  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 24090813 ↗
• MalfunctionAug 27, 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 22901524 ↗
• MalfunctionJul 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 22606272 ↗
• MalfunctionJun 4, 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 22138698 ↗
• MalfunctionSep 26, 2024Erratic or Intermittent Display; Erratic or Intermittent Display

  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 20307360 ↗
• MalfunctionAug 20, 2024Optical 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 20001792 ↗
• MalfunctionJan 26, 2023Poor Quality Image; Poor Quality Image

  DURING THE PROCEDURE THE IMAGE FREEZES. THE CUSTOMER STOPPED USING THE SCOPE AND INFORMED PENTAX OF THE PROBLEM. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16251110 ↗
• MalfunctionApr 11, 2022Break; Break

  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 14069742 ↗
• MalfunctionJul 31, 2021Optical Distortion; Optical Distortion

  CLOUDY IMAGE. THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. DATE OF EVENT NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12257139 ↗
• MalfunctionJul 30, 2021Poor Quality Image; Poor Quality Image

  POOR IMAGE QUALITY, BLACK DOTS & BLURRY IMAGE. THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. DATE OF EVENT NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250916 ↗
• MalfunctionJul 30, 2021Poor Quality Image; Poor Quality Image

  POOR IMAGE QUALITY, BLACK DOTS & BLURRY IMAGE. THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. DATE OF EVENT NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12250910 ↗
• MalfunctionJul 28, 2021Mechanical Problem; Connection Problem; Material Split, Cut or Torn; Mechanical Problem; Connection Problem; Material Split, Cut or Torn

  THE LED LIGHT FLICKERS EVEN THOUGH IT IS SWITCHED OFF. IT LIGHTS BRIGHTER DURING MOVEMENT. A/W CONNECTOR IS LOOSENED. THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236962 ↗
• MalfunctionJul 24, 2021Optical Distortion; Optical Distortion

  THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. BLUR IMAGE APPEAR DURING PROCEDURE. THE DOCTOR CHANGED ANOTHER DEVICE TO CONTINUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222420 ↗
• MalfunctionJul 21, 2021Erratic or Intermittent Display; Erratic or Intermittent Display

  THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. 3 DOTS APPEARED ON THE LENS AT 4 O'CLOCK LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200867 ↗
• MalfunctionJul 21, 2021Optical Distortion; Scratched Material; Material Split, Cut or Torn; Optical Distortion; Scratched Material; Material Split, Cut or Torn

  DATE OF EVENT NOT KNOWN FOR THE EXACT DATE, WE JUST KNOW THE YEAR THE COMPLAINT WAS SENT IN TO MANUFACTURER. THIS EVENT OCCURRED AT THE TIME OF DURING USE. THERE WAS NO REPORT OF PATIENT HARM. THE USER FOUND THAT THE OCULAR LENS WAS FOGGY AND COULDN'T OBSERVE CLEARLY. THEN THE USER CHANGED ANOTHER ONE TO GO ON OPERATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200856 ↗
• MalfunctionJul 15, 2021Poor Quality Image; Optical Distortion; Poor Quality Image; Optical Distortion

  POOR QUALITY IMAGE-BLACK DOTS ON IMAGE. THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171257 ↗