INSPIRA EPK-i8020c (UDI 04961333255825)Recalls & reported problems
Hoya Corporation · PENTAX Medical Video Processor EPK-i8020c (ORDER CODE: 91110) · Class 2
All models of INSPIRA (3)
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 04961333255825), received between May 1, 2026 and May 1, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Sparking” (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
- Sparking1
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.
MalfunctionMay 1, 2026Sparking
ON 17-APR-2026, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO PROCESSOR MODEL EPK-I8020C, SERIAL NUMBER (B)(6) IN NORTH CAROLINA, UNITED STATES. A LOUD POPPING SOUND WAS HEARD FROM THE PROCESSOR IN THE ENDOSCOPY ROOM, AND SPARKS WERE REPORTED TO HAVE SHOT OUT FROM THE SIDE OF THE PROCESSOR. THE PROCESSOR IN QUESTION WAS REPLACED WITH AN ALTERNATIVE PROCESSOR. THIS EVENT DID NOT OCCUR DURING AN ENDOSCOPIC PROCEDURE. THERE WAS NO PATIENT HARM OR PROCEDURE DELAY RESULTING FROM THIS MALFUNCTION. 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 25055055 ↗
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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