PENTAX Medical EPK-i5010Recalls & reported problems
Hoya Corporation · PENTAX Medical VIDEO PROCESSOR EPK-i5010 · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 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 04961333225804), received between Nov 24, 2023 and Nov 24, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
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.
MalfunctionNov 24, 2023Break; 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 18203727 ↗
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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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