EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190N (REF N3803141)Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04953170436772), received between Aug 8, 2023 and Jun 25, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (19 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2026Corroded; Material Puncture/Hole; Use of Device Problem; Gas/Air Leak; Material Integrity Problem; Optical Discoloration; Positioning Problem; Material Split, Cut or Torn

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED CORROSION ON THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25626327 ↗
• MalfunctionJun 18, 2026No Display/Image; Failure to Clean Adequately

  THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TECHNICIAN IDENTIFIED THAT THE DEVICE HAD A BLACK SCREEN WITH NO IMAGE AND FOREIGN MATERIAL ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555552 ↗
• MalfunctionMay 27, 2026Corroded

  THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER WITH A REPORT OF INSERTION TUBE DENTED AND ANGULATION MISADJUSTED. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, DURING THE DEVICE ANALYSIS, AN MDR REPORTABLE MALFUNCTION WAS NOTED IN WHERE CORRODED OBJECTIVE LENSES WERE OBSERVED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25298613 ↗
• MalfunctionMar 3, 2026No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24495861 ↗
• MalfunctionFeb 24, 2026No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE IMAGE IS NOT DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436585 ↗
• MalfunctionDec 17, 2025No Display/Image; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED IMAGE WITH BLUR. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23831491 ↗
• MalfunctionNov 6, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE AIR/WATER CYLINDER AND THE AIR/WATER TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20621783 ↗
• MalfunctionOct 29, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED A CLOGGED NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20559489 ↗
• MalfunctionOct 28, 2024Failure to Clean Adequately; Failure to Clean Adequately

  DURING, THE INSPECTION AND TESTING OF THE GASTROINTESTINAL VIDEOSCOPE. HAD FOREIGN MATERIAL CLOGGED NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553266 ↗
• MalfunctionOct 11, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20430053 ↗
• MalfunctionOct 3, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT DURING REPROCESSING OF THE GASTROINTESTINAL VIDEOSCOPE, CHEMICAL FORMALIN WAS USED DURING REPROCESSING OF THE SCOPE INSTEAD OF ALCOHOL. THE DEVICE WAS USED IN SUBSEQUENT PROCEDURES; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359211 ↗
• MalfunctionOct 1, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE HAD CLOGGED NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20345723 ↗
• MalfunctionSep 17, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE AIR/WATER TUBE AND AIR/WATER CYLINDER OF THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20235549 ↗
• MalfunctionAug 14, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED CLOGGED NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982609 ↗
• MalfunctionAug 13, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED REPROCESSING PROBLEMS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19975512 ↗
• MalfunctionJul 23, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL CLOGGED IN THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804878 ↗
• MalfunctionJul 2, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE ISSUE OCCURRED AT PREPARATION FOR USE FOR AN ESOPHAGOGASTRODUODENOSCOPY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19662437 ↗
• MalfunctionJun 3, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A CLOGGED AIR/WATER CHANNEL WITH FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454084 ↗
• MalfunctionMay 23, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE NOZZLE AND BENDING SECTION COVER EXHIBITED FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19383767 ↗
• MalfunctionJan 12, 2024Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THE REPROCESSING, THE GASTROINTESTINAL VIDEOSCOPE WAS NOT COMPLETING REPROCESSING CYCLES. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18504803 ↗
• MalfunctionJan 9, 2024Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE GASTROINTESTINAL VIDEOSCOPE HAD AN ERROR IN THE SCOPE IDENTIFICATION DATA AND THE CARBON DIOXIDE WAS NOT WORKING THROUGH THE SCOPE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN UNSPECIFIED DIAGNOSTIC PROCEDURE. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, A CLOGGED NOZZLE WITH FOREIGN MATERIAL STUCK INSIDE WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18479724 ↗
• MalfunctionNov 30, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE GASTROINTESTINAL VIDEOSCOPE WAS RETURNED AS PART OF THE ASSET RETURN PROCESS. DURING ROUTINE INSPECTION OF THE DEVICE BY OLYMPUS, WHITE FOREIGN MATERIAL WAS FOUND WITHIN THE AIR/WATER (A/W) CYLINDER. THERE WAS NO PROCEDURAL OR PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT. THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18243371 ↗
• MalfunctionNov 15, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE GASTROINTESTINAL VIDEOSCOPE CAUSED THE MEDIVATOR TO KEEP SAYING THERE WAS AN AIR CHANNEL BLOCK. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING EVALUATION, FOREIGN MATERIAL WAS FOUND AT THE AIR/WATER NOZZLE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THE ISSUE WAS FOUND DURING SCOPE REPROCESSING. NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18140963 ↗
• MalfunctionNov 14, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE PLASTIC ON THE HANDLE BROKE OFF OF THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE. IT WAS NOT REPORTED WHEN THE ISSUE OCCURRED OR WAS OBSERVED. THE DEVICE WAS RETURNED AND DURING THE DEVICE EVALUATION THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: WHITISH GELATINOUS FOREIGN MATERIAL WAS FOUND INSIDE THE AIR/WATER (A/W) TUBE AND CYLINDER. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18134652 ↗
• MalfunctionNov 1, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REQUESTED AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST TO OBSERVE THEIR STAFF DURING REPROCESSING OF THE EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE. AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) OBSERVED THE HANDLING OF DEVICES IN THE REPROCESSING AREA. THE ESS REPORTED OBSERVING STAFF PERFORMING PRE-CLEANING ON A DEVICE. FOR THE DEVICE IN QUESTION, THE PRE-CLEANING COULD NOT BE PERFORMED IMMEDIATELY AFTER THE PROCEDURE AND WAS DELAYED MORE THAN 1 HOUR. WHEN DEVICE PRE-CLEANING IS DELAYED, THE DEVICE REPROCESSING MANUAL INSTRUCTS THE USER TO PRESOAK THE SCOPE IN DETERGENT SOLUTION "UNTIL THE DEBRIS IS LOOSENED". THE ESS OBSERVED THE STAFF SOAKING THE SCOPE FOR ONLY 1 MINUTE BEFORE BEGINNING THE MANUAL CLEANING. IN ADDITION, THE STAFF DID NOT PERFORM THE REQUIRED LEAK TESTING PRIOR TO MANUAL CLEANING. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. THE CUSTOMER CONFIRMED THERE WAS NO IMPACT TO PROCEDURES (NO DELAYS OR CANCELLATIONS) AND THERE WAS NO IMPACT TO PATIENT (NO ADVERSE EFFECTS, NO EXTENSION OF SEDATION OR ANESTHESIA, NO MEDICAL INTERVENTION). REFER TO RELATED REPORTS WITH PATIENT IDENTIFIERS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18049131 ↗