VIDEO PROCESSOR EPK-I5010 (UDI 04961333240227)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04961333240227), received between Dec 31, 2020 and Dec 31, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2020Electrical /Electronic Property Problem; Unintended Movement; Electrical /Electronic Property Problem; Unintended Movement

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON 02-DEC-2020 STATING "DURING PRE-INSPECTION LIGHT BULB WAS REPLACED AND SPARKS COMING OUT WHEN UNIT IS TURNED ON AND LAMP DOES NO TO COME ON" INVOLVING PENTAX MEDICAL VIDEO PROCESSOR, MODEL EPK-I5010, SERIAL NUMBER (B)(4). NO OTHER INFORMATION WAS PROVIDED AT THE TIME OF THE REPORT. THE CUSTOMER OWNED VIDEO PROCESSOR WAS RETURNED TO PENTAX MEDICAL FOR EVALUATION ON 14-DEC-2020. THE PROCESSOR WAS INSPECTED BY PENTAX MEDICAL SERVICE TECHNICIAN UNDER SERVICE ORDER (B)(4) AND THE TECHNICIAN DOCUMENTED THE FOLLOWING INSPECTION FINDINGS ON 15-DEC-2020: LAMP INCORRECTLY INSTALLED, LIMIT SWITCH ACTUATOR PLATE(2) BENT, CONNECTER MOUNTING PLATE BENT, BALL PLUNGER DAMAGED, AIR SOCKET TUBE LEAKING, ELECTRICAL CONNECTOR WITH WIRING INTERMITTENT CONNECTION, SCOPE CONNECTOR HANDLE LOOSE. THE DEVICE UNDERWENT REPAIRS INCLUDING THE FOLLOWING COMPONENTS: BALL PLUNGER, CONNECTOR CAM RING, SCOPE CONNECTOR ASSY, CABLE TO LIMIT SW. MULTIPLE GOOD FAITH EFFORT ATTEMPTS WERE MADE TO THE CUSTOMER TO GATHER ADDITIONAL INFORMATION FOR THE EVENT ON 07-DEC-2020, 10-DEC-2020, AND 15-DEC-2020, AND THE CUSTOMER RESPONDED ONLY CONFIRMING THAT THE FAILURE OCCURRED DURIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11102389 ↗