VIDEO PROCESSOR EPK-3000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04961333240197), received between Dec 31, 2020 and Jul 23, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property Problem” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2021Optical Problem; Optical Problem

  PENTAX MEDICAL WAS MADE AWARE OF AN EVENT WHICH OCCURRED IN ASIA PACIFIC REGION INVOLVING PENTAX VIDEO PROCESSOR MODEL EPK-3000 SN: (B)(4). THE EVENT REPORTED ON 26JAN2021, STATED THE PROCESSOR WAS INSTALLED AND THE MAIN LAMP FAILED TO LIGHT. THE ABNORMALITY WAS OBSERVED IN THE PROCEDURE ROOM BEFORE USE. THERE WAS NO ADVERSE EVENT REPORTED WITH THIS COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS EVENT MEETS THE REQUIREMENT FOR FDA REPORTABILITY; THEREFORE, SUBMISSION OF A 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 12217227 ↗
• MalfunctionDec 31, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2020 STATING "ON (B)(6) 2020, WHEN THE LAMP WAS TURNED ON BEFORE USE, A STRANGE NOISE WAS HEARD, A SPARK WAS WITNESSED, AND THE LAMP DID NOT TURN ON. (ERROR CODE: 03-4000) NO DAMAGE DUE TO ABNORMAL NOISE AND SPARKS. WE REPLACED IT WITH A SUBSTITUTE ON (B)(6) 2020 AND CONFIRMED THE REPRODUCTION IN MITAKA.." INVOLVING PENTAX MEDICAL VIDEO PROCESSOR, MODEL EPK-3000, SERIAL NUMBER (B)(4). NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER WAS REPORTED. DURING PENTAX MEDICAL INSPECTION, THE FAILURE WAS CONFIRMED. SOFTWARE VERSION: (B)(4). SYSTEM LIFE: 487 HOURS 3 MINUTES 5 SECONDS. TOTAL LIGHTING TIME: 212 HOURS 5400 SECONDS. NUMBER OF LIGHTING: 1331 TIMES. NUMBER OF INITIALIZATION EXECUTIONS: 0 MEASURES AGAINST DUST ON LAMP POWER BOARD: NOT SUPPORTED. DOOR CHANGE: ALREADY SUPPORTED. THERE WAS A LAMP POWER FAILURE DUE TO DUST. THE REPAIRED PRODUCT WAS RETURNED TO THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103289 ↗
• MalfunctionDec 31, 2020Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  PENTAX MEDICAL WAS MADE AWARE OF A COMPLAINT ON (B)(6) 2020 STATING "ON (B)(6) 2020, WHEN THE LAMP WAS TURNED ON AFTER STARTUP, A STRANGE NOISE WAS HEARD, A SPARK WAS WITNESSED, AND THE LAMP DID NOT TURN ON. (CHECK LOG 03-4000 AND 03-1000) NO DAMAGE DUE TO ABNORMAL NOISE AND SPARKS." INVOLVING PENTAX MEDICAL VIDEO PROCESSOR, MODEL EPK-3000, SERIAL NUMBER (B)(4). NO SERIOUS INJURY OR DEATH OF A PATIENT OR USER WAS REPORTED. DURING PENTAX MEDICAL INSPECTION, THE DEVICE WAS REPLACED WITH A SUBSTITUTE AND CONFIRMED "AUX LAMP ON.CHECK MAIN LAMP". SOFTWARE VERSION: (B)(4) SYSTEM LIFE: 3256 HOURS 17 MINUTES 26 SECONDS TOTAL LIGHTING TIME: 23 HOURS 9 MINUTES 55 SECONDS NUMBER OF LIGHTING: 1340 TIMES NUMBER OF INITIALIZATION EXECUTIONS: 4 TIMES MEASURES AGAINST DUST ON LAMP POWER BOARD: NOT SUPPORTED. DOOR CHANGE: ALREADY SUPPORTED THE IGNITER WAS FOUND TO BE THE CAUSE BECAUSE THE PHENOMENON WAS IMPROVED BY REPLACING THE IGNITER INSTALLED IN THE LAMP POWER SUPPLY. FROM THE MANUFACTURER'S ANALYSIS, IT IS CONSIDERED THAT THE CAUSE OF THE ESTIMATION IS THAT THE IGNITION VOLTAGE DROPPED DUE TO THE PROXIMITY OF THE PARTS INSIDE THE IGNITER. THE REPAIRED PRODUCT WAS RETURNED TO THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11103052 ↗