GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of GASTROINTESTINAL VIDEOSCOPE (8)
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 colonoscope is the subject of 1,053 adverse event reports, which mention no deaths and 11 injuries. Many reports describe scopes that were not adequately cleaned or left residue, and others describe poor or missing images. Reports rose from 96 in the previous 12 months to 670 in the latest 12 months. 1 open recall, started in August 2024, concerns camera color settings programmed incorrectly.
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
- 990
- Deaths reported
- 0
- Injuries reported
- 11
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 990 adverse event reports that list this exact device (DI 04953170420191), received between May 9, 2023 and Sep 30, 2026 — classified as 11 injuries, 979 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (407 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
- Aug 21, 2024Class IIOpen, Classified
It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
Z-0181-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately407
- Communication or Transmission Problem153
- Residue After Decontamination95
- No Display/Image88
- Poor Quality Image80
- Device Reprocessing Problem63
- Microbial Contamination of Device40
- Thermal Decomposition of Device29
Patient problems
- No Clinical Signs, Symptoms or Conditions977
- Insufficient Information5
- Foreign Body In Patient4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Fungal Infection2
- Drug Resistant Bacterial Infection1
Recent adverse event reports
The 25 most recent of 990 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Communication or Transmission Problem
The customer returned the gastrointestinal videoscope to the service center for a separate issue. During the device analysis an E226 error was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952101 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951622 ↗MalfunctionSep 30, 2026Communication or Transmission Problem
The customer reported the Gastrointestinal videoscope scope communication error (E226) during a Inspection for use. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947966 ↗MalfunctionSep 30, 2026Erratic or Intermittent Display; No Display/Image
The customer reported the gastrointestinal videoscope had a flickering display during inspection for use. During the initial evaluation of the device, a blackout image and no image was observed. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945851 ↗MalfunctionSep 30, 2026Communication or Transmission Problem; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941472 ↗MalfunctionSep 29, 2026No Display/Image; Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50939526 ↗MalfunctionSep 29, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934777 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931692 ↗MalfunctionSep 28, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924923 ↗MalfunctionSep 28, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923435 ↗MalfunctionSep 28, 2026Failure to Clean Adequately
The customer returned the gastrointestinal videoscope for a separate issue. No patient involvement. During inspection of the returned device, it was found white residue in the air/water supply channels.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50922763 ↗MalfunctionSep 28, 2026Corroded
The customer returned the gastrointestinal videoscope for a separate issue. No patient involvement. During inspection of the returned device, it was found the air/water port inlet was rusty.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921823 ↗MalfunctionSep 28, 2026Erratic or Intermittent Display; No Display/Image; Poor Quality Image
The customer reported Black image and image Intermittent during the reprocessing involving an Olympus Gastrointestinal videoscope. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913873 ↗MalfunctionSep 24, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50890361 ↗MalfunctionSep 24, 2026Communication or Transmission Problem
The customer returned the Gastrointestinal Videoscope for a separate issue. During the initial evaluation of the returned device, scope communication error code E226 was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884986 ↗MalfunctionSep 24, 2026Failure to Clean Adequately
The customer reported that the gastrointestinal videoscope had a separate issue. During the initial evaluation of the device, white residues were observed on both sides of the air/water channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884280 ↗MalfunctionSep 24, 2026Failure to Clean Adequately
The customer reported that the gastrointestinal videoscope had a separate issue. During the initial evaluation of the device, white residue was observed in the air/water channel on both sides. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883591 ↗MalfunctionSep 24, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883208 ↗MalfunctionSep 24, 2026Material Integrity Problem
The customer reported that the gastrointestinal videoscope exhibited fibers protruding from the channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50883037 ↗MalfunctionSep 24, 2026Communication or Transmission Problem; Failure to Clean Adequately
The customer reported an E226 communication error during inspection for an unspecified procedure involving an Olympus gastrointestinal videoscope. Additionally, during the initial evaluation of the returned device a white residue was found at the air/water supply and auxiliary water tube. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882722 ↗MalfunctionSep 24, 2026Failure to Clean Adequately
The customer reported the gastrointestinal videoscope for a separate issue. During the initial evaluation of the returned device, white residue was observed in the air/water supply cylinder and channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50882700 ↗MalfunctionSep 23, 2026Poor Quality Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876213 ↗MalfunctionSep 22, 2026Residue After Decontamination; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862145 ↗MalfunctionSep 22, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50861483 ↗MalfunctionSep 22, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50860784 ↗
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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