OPTIVISTARecalls & reported problems across all models
Hoya Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 56
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of OPTIVISTA by Hoya Corporation in the FDA's device registry (GUDID). Together they are named in 56 adverse event reports in the FDA's MAUDE database, received between Jul 6, 2021 and Apr 13, 2026 — classified as 56 malfunctions.
The most frequently reported specific device problem is “Erratic or Intermittent Display” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported OPTIVISTA problems
Device problems
- Erratic or Intermittent Display16
- Break6
- Circuit Failure6
- Device Markings/Labelling Problem6
- No Display/Image6
- Product Quality Problem4
- Optical Obstruction2
- Optical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions56
- Insufficient Information1
OPTIVISTA models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OPTIVISTA EPK-i7010Endoscope, accessories, image post-processing for color enhancement53 reports
- OPTIVISTA EPK-i7010Endoscope, accessories, image post-processing for color enhancement3 reports
Recent OPTIVISTA adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 13, 2026Erratic or Intermittent Display
ON 18-MAR-2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I7010, SERIAL NUMBER (B)(6) IN CANADA WITHIN THE (B)(6). PENTAX MEDICAL RECEIVED, VIA EMAIL FROM HEALTH CANADA, A COPY OF A REPORT SUBMITTED BY THE USER FACILITY TO HEALTH CANADA (REPORT NUMBER: (B)(4) / LRN-20260311-432 / RCT-20260311-371). THE REPORT DESCRIBED THAT DURING AN ENDOSCOPIC PROCEDURE, A MALFUNCTION OCCURRED IN THE LIGHT SOURCE OF THE PROCESSOR, CAUSING THE ENDOSCOPIC IMAGE TO FLICKER FOR SEVERAL MINUTES. THE PROCEDURE WAS TEMPORARILY INTERRUPTED WHILE THE BIOMEDICAL ENGINEERING DEPARTMENT INTERVENED. THE ENDOSCOPIC IMAGE WAS NOT ADEQUATE, AND IT WAS REPORTED THAT THE PATIENT WAS EXPOSED TO POTENTIAL RISKS SUCH AS PERFORATION. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT OCCURRED DURING USE. 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 24854811 ↗MalfunctionDec 22, 2025Erratic 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 23861444 ↗MalfunctionApr 16, 2025No Display/Image; No Display/Image
ON (B)(6) 2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A MODEL EPK-I7010, SERIAL NUMBER (B)(6) VIDEO PROCESSOR IN ARGENTINA WITHIN THE PAI REGION. THE LAMP OF THE PROCESSOR DID NOT TURN ON, AND AN ERROR MESSAGE (19-06/59-06) WAS DISPLAYED. A PENTAX MEDICAL ENGINEER CHECKED THE CABLE CONNECTION AND THE OE SLIDE MOTOR BUT FOUND NO ABNORMALITIES, AND THE ISSUE WAS NOT RESOLVED. WHEN THE PROCESSOR WAS INSPECTED USING THE PERIPHERAL DEVICE CIRCUIT BOARD, IT OPERATED NORMALLY. THIS EVENT OCCURRED AT THE TIME OF DURING USE. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21847479 ↗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 ↗
Other Hoya Corporation products
All Hoya Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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