OPTIVISTA EPK-i7010 (UDI 04961333223794)Recalls & reported problems
Hoya Corporation · PENTAX Medical Video Processor EPK-i7010 · Class 2
All models of OPTIVISTA (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This PENTAX Medical EPK-i7010 video processor is a unit that processes and enhances color images from an endoscope. The 53 reports mostly describe picture problems during endoscopy — flickering or intermittent video, shadows or blackouts in the image, and units breaking or losing power. No reports describe patient injuries or deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 53
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 53 adverse event reports that list this exact device (DI 04961333223794), received between Jul 6, 2021 and Jul 19, 2024 — classified as 53 malfunctions.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (14 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Erratic or Intermittent Display14
- Break6
- Circuit Failure6
- Device Markings/Labelling Problem6
- No Display/Image5
- Product Quality Problem4
- Optical Obstruction2
- Optical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 53 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 19, 2024Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19785876 ↗MalfunctionJul 19, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19785861 ↗MalfunctionMay 21, 2024Product Quality Problem; Product Quality Problem
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. IRIS DIAPHRAGM FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19356673 ↗MalfunctionMay 15, 2024Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19317240 ↗MalfunctionApr 26, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19188985 ↗MalfunctionMar 29, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19001829 ↗MalfunctionMar 28, 2024No Display/Image; No Display/Image
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT ).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18994704 ↗MalfunctionMar 21, 2024No Display/Image; No Display/Image
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18947549 ↗MalfunctionMar 5, 2024No Display/Image; No Display/Image
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18834446 ↗MalfunctionFeb 19, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. IRIS DIAPHRAGM FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18728741 ↗MalfunctionFeb 15, 2024Unintended Movement; Unintended Movement
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. IRIS DIAPHRAGM FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18708617 ↗MalfunctionFeb 7, 2024Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. IRIS DIAPHRAGM FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18656357 ↗MalfunctionJan 17, 2024Break; 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 18523650 ↗MalfunctionDec 18, 2023Product Quality Problem; Product Quality Problem
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. IRIS DIAPHRAGM FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18342685 ↗MalfunctionNov 22, 2023Erratic 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 18189354 ↗MalfunctionOct 17, 2023Erratic 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 17947447 ↗MalfunctionSep 12, 2023Erratic 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 17726911 ↗MalfunctionAug 11, 2023Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. IRIS DIAPHRAGM FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17510315 ↗MalfunctionJul 13, 2023Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. IRIS DIAPHRAGM FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17314267 ↗MalfunctionJul 9, 2023Erratic 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 17284303 ↗MalfunctionJun 30, 2023Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17235025 ↗MalfunctionJun 25, 2023Erratic or Intermittent Display; Erratic or Intermittent Display
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17196257 ↗MalfunctionApr 4, 2023Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16671933 ↗MalfunctionFeb 1, 2023Product Quality Problem; Product Quality Problem
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. IRIS DIAPHRAGM FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16275857 ↗MalfunctionJan 23, 2023Detachment of Device or Device Component; Optical Problem; Unintended Movement; Detachment of Device or Device Component; Optical Problem; Unintended Movement
CUSTOMER REPORTED WHEN TESTING THE EQUIPMENT, THE VIDEO IMAGE IS TOO BRIGHT. THIS EVENT OCCURRED AT THE TIME OF INSTALLATION. THERE WAS NO REPORT OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16230830 ↗
Other Endoscope, accessories, image post-processing for color enhancement devices
- PENTAX Medical EC38-i20cLHoya Corporation · Endoscope, Accessories, Image Post-Processing For Color Enhancement1 recall185 reports
- PENTAX Medical EG29-i20cHoya Corporation · Endoscope, Accessories, Image Post-Processing For Color Enhancement1 recall123 reports
- INSPIRA EPK-i8020cHoya Corporation · Endoscope, accessories, image post-processing for color enhancement2 recalls24 reports
- IMAGINA EPK-i5500cHoya Corporation · Endoscope, accessories, image post-processing for color enhancement30 reports
- DEFINA EPK-3000-USPentax Of America, Inc. · Endoscope, Accessories, Image Post-Processing For Color Enhancement9 reports
- VIDEO PROCESSOR EPK-I7010Pentax Of America, Inc. · Endoscope, Accessories, Image Post-Processing For Color Enhancement8 reports
- OPTIVISTA EPK-i7010Hoya Corporation · Endoscope, accessories, image post-processing for color enhancement3 reports
- VIDEO PROCESSOR EPK-3000Pentax Of America, Inc. · Endoscope, Accessories, Image Post-Processing For Color Enhancement3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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