COLONOVIDEOSCOPE CF-Q150I (UDI 04953170307621)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of COLONOVIDEOSCOPE (12)
Data updated Oct 16, 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.
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170307621), received between Jul 15, 2022 and Jan 22, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (2 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 16, 2026.
Reports received per month
Recalls naming this device
- Sep 25, 2023Open, 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
- Poor Quality Image2
- Contamination1
- Device Reprocessing Problem1
- Failure to Clean Adequately1
- No Display/Image1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED STICKY DEFORMATION PROTECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145652 ↗MalfunctionNov 25, 2025No Display/Image; No Display/Image
NO OTHER ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23647572 ↗MalfunctionOct 23, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE EXHIBITED A BLACKOUT. THE ISSUE OCCURRED DURING INSPECTION FOR USE, BEFORE THE PATIENT ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23369100 ↗MalfunctionJul 15, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE DISPLAYED BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22509291 ↗MalfunctionMar 31, 2025Device Reprocessing Problem; Device Reprocessing Problem
DURING DEVICE EVALUATION, THE SURFACE OF THE PROTECTORS AND/OR BUTTONS OF THE SUBJECT DEVICE CONTAINED PLAQUE/FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21731137 ↗MalfunctionJul 15, 2022Contamination; Contamination
THE CUSTOMER REPORTED THAT THE SUCTION CONNECTOR WAS BLOCKED WITH FOREIGN MATERIAL. THE ISSUE WAS OBSERVED DURING REPROCESSING OF THE SUBJECT DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15030186 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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