EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS PCF TYPE H180AI (UDI 04953170339875)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04953170339875), received between Sep 26, 2019 and May 11, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Sep 25, 2023Class IIOpen, Classified

   Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

   Z-0341-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE SCOPE COVER WAS DIRTY, THE AIR WATER CYLINDER CONTAINED FOREIGN OBJECTS, AND THE AIR WATER TUBE CONTAINED FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25135570 ↗
• MalfunctionMar 3, 2026Contamination /Decontamination Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON AIR WATER CYLINDER / TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24501173 ↗
• MalfunctionDec 16, 2025Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE COLONOVIDEOSCOPE EXHIBITED LINES ON THE MONITOR. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23821113 ↗
• MalfunctionApr 23, 2025Residue After Decontamination; Residue After Decontamination

  IT WAS REPORTED THAT DURING SET UP THE COLONOVIDEOSCOPE HAD FOREIGN MATERIAL (RESIDUES) IN THE CHANNEL. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21891679 ↗
• MalfunctionMar 20, 2025Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE AIR/WATER-CYLINDER (TUBE) HAS FOREIGN OBJECTS, THE JET TUBE HAS FOREIGN OBJECTS, THE AIR/WATER TUBE HAS FOREIGN OBJECTS, THE PLASTIC DISTAL END (C-COVER) HAS FOREIGN OBJECTS, THE NOZZLE HAS FOREIGN OBJECTS, THE ADHESIVE AROUND THE OBJECTIVE LENS HAS FOREIGN OBJECTS, THE BENDING RUBBER (A-RUBBER) HAS FOREIGN OBJECTS, AND THE CONNECTING TUBE HAS FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651722 ↗
• MalfunctionMar 13, 2025Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE AIR/WATER TUBE AND CYLINDER HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21600211 ↗
• MalfunctionOct 15, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED WHITE FOREIGN MATERIAL IN THE AIR/WATER TUBE AND AIR/WATER CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20456945 ↗
• MalfunctionApr 30, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE HAD WHITE FOREIGN MATERIAL IN THE AIR/WATER CYLINDER AND TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19213779 ↗
• MalfunctionApr 8, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE AW (AIR, WATER) CYLINDER AND TUBE HAD WHITE FOREIGN MATERIAL/FOREIGN OBJECTS. AND THE JET TUBE HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068719 ↗
• MalfunctionMar 4, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18832585 ↗
• MalfunctionAug 8, 2023Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THE LOANER COLONOVIDEOSCOPE CONNECTION WAS DEFECTIVE DUE TO INCORRECT SCREWING. THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS RETURNED, EVALUATED, AND A WHITISH FOREIGN MATERIAL WAS FOUND IN THE AIR/WATER TUBE AND AIR/WATER CYLINDER. 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 17485185 ↗
• MalfunctionOct 4, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING ROUTINE TESTING, THE ENDOSCOPE TESTED POSITIVE FOR MICROBIAL CONTAMINATION. ON (B)(6) 2022, ALL CHANNELS WERE SAMPLED AND TESTED POSITIVE FOR GREATER THAN 25 COLONY FORMING UNITS (CFU) OF PSEUDOMONAS AERUGINOSA. ON (B)(6) 2022, ALL CHANNELS WERE SAMPLED AND TESTED POSITIVE FOR GREATER THAN 25 COLONY FORMING UNITS (CFU) OF GERMS (RAOULTELLA PLANTICOLA: 8 CFU, CITROBACTER FREUNDII: 1 CFU, AND PSEUDOMONAS AERUGINOSA: 14 CFU). THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN THE 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 15538053 ↗
• MalfunctionDec 13, 2021Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS FRANCE, DURING ROUTINE REPROCESSING, THE SUBJECT DEVICE WAS TESTED AND FOUND TO HAVE MICROBIAL CONTAMINATION. THE TEST RESULTS INCLUDED: SUCTION CHANNEL WITH 3 COLONY FORMING UNITS OF PSEUDOMONAS CHLORORAPHIS; AIR/WATER CHANNEL WITH 2 COLONY FORMING UNITS OF PSEUDOMONAS CHLORORAPHIS. THE CUSTOMER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THIS MEDICAL DEVICE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12984666 ↗
• MalfunctionOct 23, 2020Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MULTIPLE MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. FIRST TIME; SEPT. 21ST, 2020; AIR/WATER CHANNEL: UNSPECIFIED MICROBES (15 CFU/ENDOSCOPE), INSTRUMENT CHANNEL: UNSPECIFIED MICROBES (>25 CFU/ENDOSCOPE), SECOND TIME; SEPT. 21ST, 2020; AIR/WATER CHANNEL: UNSPECIFIED MICROBES (7 CFU/ENDOSCOPE), INSTRUMENT CHANNEL: UNSPECIFIED MICROBES (>25 CFU/ENDOSCOPE). THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, POKA YOKE (GETINGE), USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10724813 ↗
• MalfunctionMay 28, 2020Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MULTIPLE MICROBIOLOGICAL TESTING BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. [FIRST TIME; (B)(6) 2020] STENOTROPHOMONAS MALTOPHILIA (103 CFU/150ML) [SECOND TIME; (B)(6) 2020] POLYMORPHIC FLORA (COUNTLESS BACTERIA CFU/150ML) THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE SERIE4, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10099541 ↗
• MalfunctionNov 17, 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 ON THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR ENTEROBACTERIACEAE AND PSEUDOMONAS AERUGINOSA (GREATER THAN 100 CFU). THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE 4, USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9333691 ↗
• MalfunctionSep 26, 2019Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MULTIPLE MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE. -SUCTION CHANNEL AND INSTRUMENT CHANNEL: SERRATIA MARCESCENS (2 CFU/25ML). -INSTRUMENT CHANNEL: SERRATIA MARCESCENS (11 CFU/50ML) AND PSEUDOMONAS AERUGINOSA (2 CFU/50ML). THE DEVICE HAD BEEN REPROCESSED WITH A NON-OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR, SOLUSCOPE 3 AND SOLUSCOPE 4, AND SOMETIMES MANUALLY REPROCESSED USING PERACETIC ACID. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9126718 ↗