COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DIRecalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of COLONOVIDEOSCOPE (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus colonoscope is an endoscope used to look inside the colon. Most reports describe the scope not being cleaned adequately, and some describe microbial contamination inside it or foreign objects found in its air and water tubes during evaluation. There are 260 reports, with no deaths and no injuries. Reports fell to 1 in the last 12 months from 16 in the year before. No recalls name this device.
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
- 261
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 261 adverse event reports that list this exact device (DI 04953170424298), received between Jun 20, 2023 and Sep 8, 2026 — classified as 261 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (188 reports).
1 other recall cover devices cleared under the same FDA submission (K222584); they may or may not involve this specific model.
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
Most reported problems
Device problems
- Failure to Clean Adequately188
- Microbial Contamination of Device58
- Device Reprocessing Problem15
- Communication or Transmission Problem6
- Thermal Decomposition of Device6
- Contamination /Decontamination Problem3
- Partial Blockage2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions261
Recent adverse event reports
The 25 most recent of 261 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Communication or Transmission Problem
The customer returned the colonovideoscope for a separate issue. During the initial evaluation of the returned device, B30 (scope communication error). No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675747 ↗MalfunctionJul 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50080545 ↗MalfunctionMar 10, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21569051 ↗MalfunctionFeb 5, 2025Failure 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, AIR/WATER TUBE, AND IN THE JET TUBE (J-TUBE). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21315607 ↗MalfunctionJan 30, 2025Device Reprocessing Problem; Obstruction of Flow; Device Reprocessing Problem; Obstruction of Flow
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR/WATER CYLINDER, TUBE AND AUXILIARY JET TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21277796 ↗MalfunctionJan 17, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE FOLLOWING: THERE WAS FOREIGN MATERIAL IN AIR/WATER CYLINDER AND TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21181592 ↗MalfunctionJan 16, 2025Microbial Contamination of Device; Microbial Contamination of Device
THE SUBJECT DEVICE TESTED POSITIVE FOR 215 COLONY FORMING UNITS (CFUS) OF ENTEROBACTERIA, PSEUDOMONAS, AND STAPHYLOCOCCUS AUREUS. ALL CHANNELS WERE SAMPLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21169733 ↗MalfunctionDec 13, 2024Partial Blockage; Partial Blockage
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20927631 ↗MalfunctionDec 6, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT THE COLONOVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. 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 20865736 ↗MalfunctionDec 3, 2024Partial Blockage; Failure to Clean Adequately; Partial Blockage; Failure to Clean Adequately
NO ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20834239 ↗MalfunctionNov 22, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE SCOPE TESTED POSITIVE FOR 17 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA. ALL CHANNELS WERE SAMPLED. 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 20758856 ↗MalfunctionNov 21, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR MORE THAN 100 COLONY FORMING UNITS (CFUS) OF ENTEROBACTER SP.. AND KLEBSIELLA SP.. ALL CHANNELS WERE SAMPLED. 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 20752061 ↗MalfunctionNov 14, 2024Defective Device; Defective Device
IT WAS REPORTED, THE COLONOVIDEOSCOPE ASSET CHECK FAILED REQUIRING REPAIR. THE ISSUE OCCURRED DURING PREVENTIVE MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20687959 ↗MalfunctionNov 11, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE COLONOVIDEOSCOPE EXHIBITED NOZZLE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20656462 ↗MalfunctionNov 8, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE JET TUBE OF THE COLONOVIDEOSCOPE WAS CLOGGED WITH FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20639312 ↗MalfunctionNov 7, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED A CLOGGED NOZZLE BY A DARK RUBBERY MATERIAL THAT COULDN'T BE REMOVED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20633053 ↗MalfunctionNov 7, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE COLONOVIDEOSCOPE EXHIBITED A WHITISH FOREIGN MATERIAL WAS FOUND INSIDE OF THE AIR/WATER CYLINDER AND AIR/WATER TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20632029 ↗MalfunctionNov 6, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS WITHIN THE AIR/WATER TUBE AND CYLINDER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20616439 ↗MalfunctionOct 31, 2024Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED HAVING USED THE COLONOVIDEOSCOPE ON SIX PATIENTS WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. 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 20582983 ↗MalfunctionOct 31, 2024Microbial Contamination of Device; Failure to Clean Adequately; Microbial Contamination of Device; Failure to Clean Adequately
CORRECTION TO B5 OF THE INITIAL REPORT: THE CUSTOMER REPORTED HAVING USED THE COLONOVIDEOSCOPE ON 6 OF PATIENTS WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. 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 20579323 ↗MalfunctionOct 31, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE COLONOVIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE AIR-WATER TUBE, AND FOREIGN OBJECTS IN THE JET-TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577214 ↗MalfunctionOct 30, 2024Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED HAVING USED THE COLONOVIDEOSCOPE ON SIX PATIENTS WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. 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 20571333 ↗MalfunctionOct 30, 2024Microbial Contamination of Device; Failure to Clean Adequately; Microbial Contamination of Device; Failure to Clean Adequately
THE CUSTOMER REPORTED HAVING USED THE COLONOVIDEOSCOPE ON 6 OF PATIENTS WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. 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 20566496 ↗MalfunctionOct 30, 2024Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED HAVING USED THE COLONOVIDEOSCOPE ON SIX PATIENTS WHILE AWAITING THE RESULTS FOR ROUTINE CULTURE TESTING. POSITIVE CULTURE TEST RESULTS WERE SUBSEQUENTLY RECEIVED. 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 20565712 ↗MalfunctionOct 29, 2024Microbial Contamination of Device; Microbial Contamination of Device
IT WAS REPORTED THAT, DURING REPROCESSING, THE COLONOVIDEOSCOPE TESTED POSITIVE FOR 6 COLONY FORMING UNITS (CFUS) OF PSEUDOMONAS AERUGINOSA. ALL CHANNELS WERE SAMPLED. 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 20558573 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K222584. One submission often covers many models, so check the product and lot details in each record.
- Z-0181-2025 · Aug 21, 2024 · Open, ClassifiedOlympus Gastrointestinal Videoscope, Model/Catalog Number: GIF-1100
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
- 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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