EVIS EXERA II COLONOVIDEOSCOPE OLYMPUS CF TYPE H180AL (UDI 04953170339608)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
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus colonoscope is a flexible scope used to view the colon. The 70 reports that name its identifier mostly describe cleaning problems and contamination found during servicing, along with loss of image or light, with no deaths and 1 injury mentioned. There are 2 open recalls, one about missing adhesive that protected repaired scopes from vibration and temperature changes and one about repair returns with a wet channel that could become contaminated.
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
- 72
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 04953170339608), received between Mar 9, 2019 and Sep 24, 2026 — classified as 1 injury, 71 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (32 reports).
2 FDA recall records name this device's identifier, 2 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
- Jan 11, 2024Class IIOpen, Classified
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
Z-1205-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- 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
- Failure to Clean Adequately32
- Microbial Contamination of Device15
- Device Reprocessing Problem9
- No Display/Image5
- Contamination3
- Corroded3
- Communication or Transmission Problem2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions64
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- Abdominal Pain1
- Bowel Perforation1
- Diaphoresis1
- Discomfort1
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 72 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 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 that a black foreign material at nozzle was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876998 ↗MalfunctionSep 1, 2026Corroded
During onsite inspection of the colonovideoscope, it was found that nozzle had corrosion. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50544476 ↗MalfunctionAug 25, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50435173 ↗MalfunctionJul 28, 2026No Display/Image; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50057828 ↗MalfunctionJul 27, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50048218 ↗MalfunctionJun 25, 2026Failure to Clean Adequately
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS THE SERVICE TECHNICIAN, INDICATES THAT A DIRT IN THE LENSES WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25620556 ↗MalfunctionJun 23, 2026Device Reprocessing Problem
THE CUSTOMER RETURNED THE COLONOVIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT AN AIR WATER CYLINDER AND TUBE HAS FOREIGN MATERIAL WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25598081 ↗MalfunctionJun 2, 2026Output Problem
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE EXHIBITED NO ILLUMINATION IN THE THIRD LIGHT GUIDE LENS. THE ISSUE OCCURRED DURING THE INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25365584 ↗MalfunctionMay 26, 2026No Display/Image
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD NO IMAGE. THIS ISSUE WAS FOUND DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25283986 ↗MalfunctionMay 21, 2026Failure to Clean Adequately
THE COLONOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF LEAKY CONTROL HANDLE AND FOGGING OF OPTICS. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, DIRT IN THE FIELD OF VIEW WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247735 ↗MalfunctionMay 21, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS INSIDE THE AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25247490 ↗MalfunctionMay 21, 2026Communication or Transmission Problem
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE HAD A COMMUNICATION PROBLEM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25244686 ↗MalfunctionMay 8, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN OBJECTS IN UNIVERSAL CORD. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25129688 ↗MalfunctionApr 17, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN MATERIAL ON BIOPSY CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24912508 ↗MalfunctionApr 7, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24808928 ↗MalfunctionMar 9, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECT IN THE AIR WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24552057 ↗MalfunctionFeb 27, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A BLACK FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24473687 ↗MalfunctionFeb 3, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED LIGHT GUIDE ROD LENS WITH FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24243729 ↗MalfunctionFeb 2, 2026Overheating of Device; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS COMING OUT OF THE DISTAL END, AND THE C-COVER SHOWED A BURN. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24235276 ↗MalfunctionJan 28, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD A FOREIGN OBJECT AT AIR/WATER TUBE AND AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202725 ↗MalfunctionJan 20, 2026Device Reprocessing Problem; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD WHITE FOREIGN MATERIAL IN AIR/WATER CYLINDER AND J-TUBE, AND THAT CONNECTING TUBE HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24114346 ↗MalfunctionJan 20, 2026Obstruction of Flow; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS FROM AUXILIARY CHANNEL AND CLOGGING OF AUXILIARY CHANNEL IN CONTROL UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24112945 ↗MalfunctionJan 15, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24083084 ↗MalfunctionJan 14, 2026Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD AN ERROR E217 (SCOPE ERROR). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24069995 ↗MalfunctionJan 7, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE HAD FOREIGN MATERIAL ON AIR-WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23988059 ↗
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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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