OPTIVISTA EPK-i7010 (UDI 04961333233618)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333233618), received between Apr 16, 2025 and Apr 13, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Erratic or Intermittent Display” (2 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 3 most recent of 3 reports, 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 ↗