EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AI (UDI 04953170339585)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA II COLONOVIDEOSCOPE (28)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA II colonoscope, a flexible scope used to view the colon, has 115 adverse event reports on file. Many describe microbial contamination or inadequate cleaning, and some describe foreign objects in the channels. The reports include no deaths and 1 injury. There is 1 open recall, which began in September 2023 over scopes that may have been returned with water left in their channels, which carries a risk of infection.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 117
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 04953170339585), received between May 15, 2018 and Sep 18, 2026 — classified as 1 injury, 116 malfunctions.
The most frequently reported specific device problem is “Microbial Contamination of Device” (51 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.
Reports received per month
Recalls naming this device
- 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-0329-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Microbial Contamination of Device51
- Failure to Clean Adequately38
- Device Reprocessing Problem13
- Contamination5
- Poor Quality Image3
- Contamination /Decontamination Problem2
- Thermal Decomposition of Device2
- Complete Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions91
- No Known Impact Or Consequence To Patient21
- No Consequences Or Impact To Patient5
- Drug Resistant Bacterial Infection1
Recent adverse event reports
The 25 most recent of 117 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Melted
The customer reported a separate issue with the colonovideoscope. During the initial evaluation of the device, a burned C-cover was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819408 ↗MalfunctionSep 1, 2026Erratic or Intermittent Display; Poor Quality Image
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550202 ↗MalfunctionAug 14, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50245709 ↗MalfunctionJun 26, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE TECHNICAL ASSISTANCE INDICATES FOREIGN MATERIAL AT THE AUXILIARY JET CHANNEL AND C-COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25640589 ↗MalfunctionJun 8, 2026Device Reprocessing Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION RELATED TO A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THE DEVICE HAD TRACES OF DISINFECTANT IN ELECTRONIC CONNECTOR AND SCOPE CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25436667 ↗MalfunctionMay 18, 2026Contamination
IT WAS REPORTED THAT THE INSERTION TUBE OF THE COLONOVIDEOSCOPE SHOWED DEPOSITS. THIS ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25201393 ↗MalfunctionMay 10, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN JET TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25133744 ↗MalfunctionMay 3, 2026Device Reprocessing Problem
IT WAS OBSERVED DURING DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN JET TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25062533 ↗MalfunctionMar 20, 2026Microbial Contamination of Device
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE SCOPE TESTED POSITIVE FOR MORE THAN 80 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA. ALL CHANNELS WERE SAMPLED. 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 24648686 ↗MalfunctionFeb 24, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS ON AIR-WATER-CYLINDER (TUBE) AND JET TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24437098 ↗MalfunctionFeb 24, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER CYLINDER, AIR/WATER TUBE AND IN THE AUXILIARY JET CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24425181 ↗MalfunctionJan 30, 2026Complete Blockage; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE AUXILIARY JET CHANNEL (J-TUBE) AND CONNECTING TUBE (C-TUBE) HAD FOREIGN OBJECTS, AND AUXILIARY JET CHANNEL (J-TUBE) IN THE CONTROL UNIT WAS CLOGGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24226458 ↗MalfunctionJan 28, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A FOREIGN OBJECTS COME OUT OF DISTAL END AND WHITE FIBROUS FOREIGN MATERIAL WAS PRESENT AT THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24197987 ↗MalfunctionJan 27, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED CORROSION ON THE AUXILIARY TUBE UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24190420 ↗MalfunctionJan 27, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN AIR WATER TUBE, C-COVER, LIGHT GUIDE LENS, CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24186356 ↗MalfunctionJan 14, 2026Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A DAMAGED SUPPORTABLE SLEEVE WITH A CUT IN THE METAL BRAID CABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067928 ↗MalfunctionJan 5, 2026Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR: ON (B)(6) 2025, ALL CHANNELS SAMPLED, 13 COLONY FORMING UNITS (CFUS) OF ESCHERICHIA HERMANII. ON (B)(6) 2025 (CONTROL), ALL CHANNELS SAMPLED, 15 COLONY FORMING UNITS (CFUS) OF ACINETOBACTER BAUMANNII, ESCHERICHIA HERMANII, METHYLOBACTERIUM SPECIES, AND MICROCOCUCUS LULEUS. ON (B)(6) 2025 (RECHECK), ALL CHANNELS SAMPLED, 2 COLONY FORMING UNITS (CFUS) OF DERMACOCCUS SP. ON (B)(6) 2025 (RECHECK), ALL CHANNELS SAMPLED, 20 COLONY FORMING UNITS (CFUS) OF MICROCOCCI SPP, COAGULASE-NEGATIVE STAPHYLOCOCCI, STAPHYLOCOCCUS SAPROPHYTICUS, ACINETOBACTER BAUMANNII, DERMACOCCUS SP, AND PRIESTIA SP. 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 23959813 ↗MalfunctionDec 22, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE EXHIBITED DISTORTED IMAGE AND NO IMAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865013 ↗MalfunctionNov 18, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE AIR/WATER CYLINDER EXHIBITED FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23586162 ↗MalfunctionNov 13, 2025Microbial Contamination of Device; Microbial Contamination of Device
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23550409 ↗MalfunctionNov 12, 2025Microbial Contamination of Device; Microbial Contamination of Device
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23532903 ↗MalfunctionOct 28, 2025Microbial Contamination of Device; Microbial Contamination of Device
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23403030 ↗MalfunctionSep 17, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATTER IN THE AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23075768 ↗MalfunctionSep 9, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN THE AUXILIARY CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23003546 ↗MalfunctionAug 26, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED FOREIGN OBJECTS IN THE JET TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22894060 ↗
Other Colonoscope and accessories, flexible/rigid devices
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths6,804 reports
- EVIS EXERA III XENON LIGHT SOURCE OLYMPUS CLV-190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid6,617 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls5 deaths6,244 reports
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190Olympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls7 deaths5,572 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2,830 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS PCF-H190LOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid3 recalls2 deaths2,513 reports
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-H190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid1 recall1,967 reports
- PENTAX Medical EC38-i10cLHoya Corporation · Colonoscope and accessories, flexible/rigid1,618 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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