DEFINA EPK-3000-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04961333225262), received between Jul 6, 2021 and Aug 5, 2021 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Optical Problem” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2021Failure to Power Up; Failure to Power Up

  THIS EVENT OCCURRED BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM. CAN NOT POWER ON. A PROBLEM HAD OCCURRED 4 DAYS AFTER THE LAST REPAIR HAD BEEN COMPLETED DELIVERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12278851 ↗
• MalfunctionAug 4, 2021Mechanical Problem; Mechanical Problem

  WHEN THE LAMP WAS LIT ON (B)(6) 2021, A LAMP LIGHTING FAILURE (ERROR 03-1000) OCCURRED. WHEN I PRESSED THE LAMP BUTTON AGAIN, IT TURNED ON, SO THERE WAS NO PROBLEM WITH THE INSPECTION. THERE ARE 4 OCCURRENCE HISTORIES IN THE ERROR LOG DURING MARCH. I DON'T KNOW IF IT'S THE DIRECT CAUSE, BUT THERE IS A WHITISH DEPOSIT ON THE RIGHT TERMINAL OF THE LAMP MOUNTING PART AND ITS SURROUNDINGS. (SEE ATTACHED IMAGE) SINCE IT OCCURRED BEFORE USE, THERE IS NO HEALTH HAZARD TO PATIENTS AND HEALTHCARE PROFESSIONALS. SOFTWARE VERSION: 00B8C-1.3000, SYSTEM LIFE: 3671 HOURS 16 MINUTES 13 SECONDS, CUMULATIVE LIGHTING TIME: 147 HOURS 20 MINUTES 31 SECONDS, NUMBER OF LIGHTS: 2198 TIMES, INITIALIZATION EXECUTION COUNT: 9 TIMES. LAMP POWER SUPPLY BOARD DUST COUNTERMEASURES: MEASURES HAVE BEEN TAKEN. DOOR CHANGE: MEASURES TAKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272345 ↗
• MalfunctionJul 28, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  THIS EVENT OCCURRED DURING USE. THERE WAS NO REPORT OF PATIENT HARM. (B)(6) 2021 ERROR MESSAGE 03-4000 TROUBLE OCCURRED WHEN ENTERING THE AUXILIARY LIGHT WHILE USING THE INSPECTION. SUBSTITUTE REPLACEMENT IS CARRIED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236984 ↗
• MalfunctionJul 24, 2021Circuit Failure; Circuit Failure

  THIS EVENT OCCURRED AT THE TIME OF DURING INSPECTION. THERE WAS NO REPORT OF PATIENT HARM. PROCESSOR FREEZING DURING PROCEDURES. NOBODY HURT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222407 ↗
• MalfunctionJul 21, 2021Image Display Error/Artifact; Image Display Error/Artifact

  THIS EVENT OCCURED DURING USE. THERE WAS NO REPORT OF PATIENT HARM. RETRY - C FUNCTION. FREEZE RELEASE - F FUNCTION OF FR2-KEY ON KBD WHERE ERROR MESSAGES OCCUR FREQUENTLY . THE LOCK LEVER IS STIFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12200819 ↗
• MalfunctionJul 19, 2021Optical Problem; Optical Problem

  IT WAS INFORMED THAT THE AMOUNT OF LIGHT WAS DARKER THAN THE FACILITY AND COULD NOT BE USED FOR MEDICAL EXAMINATIONS. THE AMOUNT OF LIGHT FROM THE LIGHT GUIDE INSERTION PART IS DARK ENOUGH TO BE SEEN, AND IT SEEMS THAT THE DIAPHRAGM IS NOT WORKING. CHECK THE LOG IN-HOUSE. NO ERROR LOG IS OUTPUT. THE PHENOMENON IS NOT REPRODUCED. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12186981 ↗
• MalfunctionJul 16, 2021Optical Problem; Optical Problem

  THE LAMP DID NOT LIGHT AND ERROR CODE 03-4000 (MAIN LAMP LIGHTING FAILURE) OCCURRED. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178906 ↗
• MalfunctionJul 15, 2021Ambient Noise Problem; Optical Problem; Ambient Noise Problem; Optical Problem

  ERROR CODE 03-2400 DISPLAYED. THERE IS ALSO A HIGH-PITCHED NOISE FROM INSIDE THE MAIN BODY. THE LAMP BUTTON BLINKS (CANNOT BE CONFIRMED). AFTER RESTARTING, THE SYMPTOMATOLOGY DISAPPEARS AND IT CAN USE IT. THIS EVENT OCCURRED AT THE TIME OF BEFORE USE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171255 ↗
• MalfunctionJul 6, 2021Failure to Transmit Record; Failure to Transmit Record

  ERROR CODE 03-0040 OCCURRED WHEN CONNECTING TO SCOPE BEFORE USE. THERE IS ONLY ONE SCOPE AND IT DOES NOT OCCUR WITH THE OTHER EPK-3000. SINCE IT OCCURRED BEFORE USE, THERE IS NO HEALTH HAZARD TO PATIENTS AND MEDICAL STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119623 ↗