VIDEO PROCESSOR EPK-I5010 (UDI 04961333232598)Recalls & reported problems
Pentax Of America, Inc. · VIDEO PROCESSOR (US USED) · Class 2
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 04961333232598), received between Aug 14, 2020 and Aug 14, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “No Display/Image” (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
- No Display/Image1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 14, 2020No Display/Image; No Display/Image
ON 15-JUL-2020 PENTAX MEDICAL RECEIVED A CUSTOMER REPORT STATING VIDEO PROCESSOR, MODEL EPK-I5010, SERIAL NUMBER (B)(4) WAS INVOLVED IN A MALFUNCTION EVENT. THE USER REPORTED "NO IMAGE- SCOPE CUTS OUT DURING PROCEDURE THAT LEAD TO MEDICAL INTERVENTION OF ADDITIONAL ANESTHESIA AND A POSSIBLE DELAY THAT PUT THE PATIENT AT RISK FOR ADVERSE EVENTS." THE USER FACILITY RESPONDED TO A GOOD FAITH EFFORT(GFE) ATTEMPT VIA EMAIL ON 15-JUL-2020 AND NOTED THE REPORTED NO IMAGE OCCURRED DURING A TREATMENT PROCEDURE ON (B)(6) 2020. THERE WAS NO INJURY REPORTED, BUT THERE WAS A DELAY IN THE PROCEDURE WHICH RESULTED IN ADDITIONAL ANESTHESIA WHICH THE USER FELT POSSIBLY PUT THE PATIENT AT RISK FOR AN ADVERSE EVENT, ALTHOUGH NONE WERE REPORTED. THE PRODUCT REMOVED FROM CIRCULATION IMMEDIATELY AFTER THE FAILURE/EVENT OCCURRED AND SUBSEQUENTLY CALLED IN FOR SERVICE/REPLACE. THE PATIENT INFORMATION WAS REQUESTED BUT NOT PROVIDED BY THE USER. THE CUSTOMER OWNED PROCESSOR WAS RECEIVED BY PENTAX MEDICAL FOR EVALUATION ON 14-JUL-2020. THE VIDEO PROCESSOR WAS EVALUATED AND AFTER THREE DAYS OF TESTING THE SERVICE REPAIR TECHNICIAN WAS UNABLE TO REPRODUCE THE CUSTOMERS REPORTED EXPERIENCE. SINCE THE USER CONTA
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10410760 ↗
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- 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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