PENTAX EPK-i5010Recalls & reported problems
Hoya Corporation · PENTAX VIDEO PROCESSOR EPK-i5010 · Class 2
All models of PENTAX (72)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333225781), received between Jul 30, 2021 and Jul 30, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Circuit Failure” (1 report).
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.
Most reported problems
Device problems
- Circuit Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2021Circuit Failure; Circuit Failure
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. WITH DIM LIGHT AND "BACKUP LIGHT ON" MESSAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12251122 ↗
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
- OPTIVISTA EPK-i7010Hoya Corporation · Endoscope, accessories, image post-processing for color enhancement53 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
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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