EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF TYPE N180 (UDI 04953170202261)Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04953170202261), received between Apr 14, 2019 and Jul 9, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (9 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 9, 2026Failure to Clean Adequately

  THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE FIELD SERVICE ENGINEER IDENTIFIED THAT THE DEVICE EXHIBITED FOREIGN MATERIAL WITHIN THE ADHESIVES AROUND THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25773454 ↗
• MalfunctionJun 16, 2026Corroded

  THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT CORROSION AROUND OBJECTIVE LENS ADHESIVE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25524309 ↗
• MalfunctionDec 1, 2025Material Integrity Problem; Material Integrity Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23686912 ↗
• MalfunctionNov 24, 2025Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A FLASHING IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23633724 ↗
• MalfunctionJul 16, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE SUBJECT DEVICE HAD A BLURRED IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22520203 ↗
• MalfunctionJun 16, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED NOZZLE HAS FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22213331 ↗
• MalfunctionOct 4, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE AIR CHANNEL WAS CLOGGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20368318 ↗
• MalfunctionSep 25, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED PLASTIC DISTAL END COVER WITH FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20306456 ↗
• MalfunctionSep 18, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A NOZZLE CLOGGED BY BLACK RUBBERY MATERIAL (FOREIGN MATERIAL). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250997 ↗
• MalfunctionAug 26, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE PROBE COVER OF THE VIDEOSCOPE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20063420 ↗
• MalfunctionOct 1, 2023Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD TOO MUCH PRESSURE IN THE AIR/WATER CHANNEL DURING AN RHINAER TREATMENT. THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS RETURNED, EVALUATED, AND A FOREIGN OBJECT WAS IN THE NOZZLE. 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 17849540 ↗
• MalfunctionSep 28, 2023Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE SHEATHING WAS WORN AND HAD LOOSE TIE RODS. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: FOREIGN MATERIAL IN THE NOZZLE AND FORCEPS CHANNEL PORT. 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 17839425 ↗
• MalfunctionMar 27, 2023Poor Quality Image; Poor Quality Image

  THE CUSTOMER REPORTED THAT THE SUBJECT DEVICE WAS LEAKING FROM THE INSERTION TUBE SECTION. THERE WAS NO PATIENT OR USER INJURY REPORTED. THE OLYMPUS FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER AND INSPECTED THE SUBJECT DEVICE, CONFIRMING THE LEAK IN THE BENDING SECTION OF THE INSERTION TUBE, AND ALSO OBSERVED WRINKLING/BUCKLING ON THE CONNECTING TUBE. THE DEVICE WAS SENT TO AN OLYMPUS SERVICE CENTER FOR FURTHER EVALUATION. DURING INSPECTION AND TESTING, SERVICE FOUND THE ENDOSCOPIC IMAGE DISPLAYED WAS BLURRY. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION [BLURRED IMAGE] FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16618756 ↗
• MalfunctionJan 11, 2023Device Contamination with Chemical or Other Material; Failure to Clean Adequately; Device Contamination with Chemical or Other Material; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE HAD CLOGGED CHANNELS. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16138089 ↗
• MalfunctionMar 18, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR 10 COLONY FORMING UNIT (CFU) OF MIXED SPP. THE INSTRUMENT CHANNEL WAS SAMPLED. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. SAMPLING WAS TAKEN AT REPROCESSING, BEFORE USE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13803963 ↗
• MalfunctionNov 10, 2021Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED BY THE CUSTOMER, ALL CHANNELS WERE SAMPLED AND THE EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE TESTED POSITIVE FOR TWENTY-SIX (26) COLONY FORMING UNITS (CFUS) OF MICROORGANISMS. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12786686 ↗
• MalfunctionMar 18, 2021Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, LEIFSONIA SP (3 CFU) WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11511669 ↗
• MalfunctionSep 1, 2020Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4) (OEKG), IT WAS FOUND THAT THE RUBBER OF THE BENDING SECTION OF THE SUBJECT DEVICE HAD BEEN TORN AND THE INNER METAL HAD BEEN PROTRUDING. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10475550 ↗
• MalfunctionJun 1, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING REPROCESSING, THE DEVICE WAS FOUND TO BE LEAKING AT THE DISTAL TIP.

  Patient problems: No Patient Involvement

  MAUDE report 10105415 ↗
• MalfunctionMay 27, 2020Break; Break

  IT WAS REPORTED THAT THE SCOPE WAS FOUND TO HAVE A WATER LEAK AND FLUID INVASION. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORT. NO USER IMPACT OR HARM WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10093976 ↗
• MalfunctionFeb 27, 2020Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, BACTERIA WERE DETECTED FROM THE WATER SAMPLE COLLECTED FROM THE SUBJECT DEVICE. OTHER DETAILED INFORMATION SUCH AS THE NUMBER OF MICROBES OR THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9767373 ↗
• MalfunctionFeb 17, 2020Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE AIR/WATER CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR UNSPECIFIED MICROBES. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION SUCH AS THE NUMBER AND THE TYPE OF MICROBES. OTHER DETAILED INFORMATION SUCH AS THE REPROCESSING METHOD WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9715808 ↗
• MalfunctionOct 29, 2019Microbial Contamination of Device; Microbial Contamination of Device

  THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED TO PROVIDE ADDITIONAL INFORMATION. THE DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL, MINIETD2 (NOT AVAILABLE IN THE USA), USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9248570 ↗
• MalfunctionApr 14, 2019Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF ROUTINE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUCTION CHANNEL OF THE SUBJECT DEVICE TESTED POSITIVE FOR CHAMPIGNONS FILAMENTEUX AND UNSPECIFIED MICROBES (THE TOTAL CFU OF THE COAGULASE- CHAMPIGNONS FILAMENTEUX AND UNSPECIFIED MICROBES IS 8CFU/100ML). THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE SERIE 4, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8512685 ↗