EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DLRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of EVIS EXERA III COLONOVIDEOSCOPE (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus EVIS EXERA III colonoscope is a flexible scope used for colon exams. Its 2,767 reports mostly describe scopes not cleaning fully during reprocessing, no picture or poor image quality, and communication problems. The reports include no deaths and 30 injuries, and most list no clinical signs in the patient. Reports in the last 12 months (1,806) are far above the previous 12 months (275). There are 3 open recalls, covering scopes repaired without adhesive, connector repairs that may cause image loss, and some scopes returned with wet channels.
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
- 2,830
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls naming it
- 3
Summary
The FDA's MAUDE database contains 2,830 adverse event reports that list this exact device (DI 04953170363672), received between Aug 14, 2018 and Sep 30, 2026 — classified as 30 injuries, 2,800 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (1,053 reports).
3 FDA recall records name this device's identifier, 3 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-1210-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
- Oct 16, 2023Class IIOpen, Classified
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
Z-0418-2024 · Root cause: Process control · 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-0341-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately1,053
- Communication or Transmission Problem454
- No Display/Image369
- Residue After Decontamination257
- Device Reprocessing Problem239
- Poor Quality Image182
- Microbial Contamination of Device146
- Contamination116
Patient problems
- No Clinical Signs, Symptoms or Conditions2,781
- Insufficient Information17
- No Consequences Or Impact To Patient16
- Diarrhea14
- Fever13
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available4
- No Patient Involvement4
- Injury3
Recent adverse event reports
The 25 most recent of 2,830 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954920 ↗MalfunctionSep 30, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949736 ↗MalfunctionSep 30, 2026No Display/Image; Communication or Transmission Problem
The customer reported that the colonovideoscope displayed a connection error during inspection for use. During the initial evaluation of the device, no image was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946029 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50938094 ↗MalfunctionSep 29, 2026Residue After Decontamination
The customer reported the colonovideoscope for a separate issue. During the initial evaluation of the device, the white residue in air water channel and cylinder was observed. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936284 ↗MalfunctionSep 29, 2026Physical Resistance/Sticking
The customer reported port had something in it and brush will not go through during an reprocessing involving an Olympus colonovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935793 ↗MalfunctionSep 29, 2026Residue After Decontamination; Output Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, white residue was observed within the air/water channel and air/water cylinder, and no illumination was observed from the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931686 ↗MalfunctionSep 28, 2026Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926021 ↗MalfunctionSep 28, 2026No Display/Image; Communication or Transmission Problem
The customer reported scope error E217 and Image may not be displayed correctly involving an Olympus Colonovideoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50918189 ↗MalfunctionSep 28, 2026Erratic or Intermittent Display; No Display/Image
The customer reported the Colonovideoscope had static on the monitor and no picture during inspection for use. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917036 ↗MalfunctionSep 28, 2026Residue After Decontamination
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, white residue on air water supply was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916360 ↗MalfunctionSep 28, 2026Residue After Decontamination
The customer reported the colonovideoscope for a separate issue. During the initial evaluation of the device, the white residue in auxiliary water channel, air water channel and cylinder was observed. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50914164 ↗MalfunctionSep 28, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, Air water supply cylinder and channel had white residue. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913772 ↗MalfunctionSep 28, 2026Communication or Transmission Problem; Failure to Clean Adequately
The customer reported Communication Error B30 (Scope communication error) during inspection for use involving an Olympus Colonovideoscope. Additionally, during the initial evaluation of the device, air water channel with white residue on both sides and production incorrect, minor scratches in the Radio Frequency identification were observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50910631 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50906258 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, Air water cylinder and tube had foreign objects. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903414 ↗MalfunctionSep 25, 2026No Display/Image; Poor Quality Image
The customer reported that when the Colonovideoscope is plugged in it is all black and fuzzy during inspection for use. During the initial evaluation of the device it was observed that there is no image. No patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900971 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, foreign objects observed in Air water tube and Cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900348 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
The customer reported scope communication error B30 during an inspection for use involving an Olympus colonovideoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50897519 ↗MalfunctionSep 25, 2026Communication or Transmission Problem
The customer reported that the colonovideoscope displayed a scope communication error (B30) during inspection prior to use. During the initial evaluation of the device, a scope communication error (E216) was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892956 ↗MalfunctionSep 25, 2026Residue After Decontamination; Communication or Transmission Problem
The customer reported that the colonovideoscope displayed a scope communication error (E216) during inspection prior to use. During the initial evaluation of the device, white residue was observed within the auxiliary water channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50892881 ↗MalfunctionSep 24, 2026Output Problem
The customer reported the colonovideoscope had a separate issue. During the initial evaluation of the device, no light was observed. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882442 ↗MalfunctionSep 24, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876518 ↗MalfunctionSep 23, 2026Poor Quality Image; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50875427 ↗MalfunctionSep 23, 2026Communication or Transmission Problem; Output Problem
The customer returned the colonovideoscope for a separate issue. During initial evaluation of the returned device, it was found that error code E216 (Scope communication error code) and not data transmission. There was no patient involvement reported. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873345 ↗
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 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
- EVIS EXERA lll COLONOVIDEOSCOPE OLYMPUS CF-HQ190IOlympus Medical Systems Corp. · Colonoscope and accessories, flexible/rigid2 recalls1,315 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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