EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190 (UDI 04953170305290)Recalls & reported problems
Olympus Medical Systems Corp. · GIF-H190 EVIS EXERA III HDTV GASTROSCOPE · Class 2
All models of EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE (7)
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 EVIS EXERA III gastroscope is a flexible endoscope. The reports often describe scopes not cleaning adequately, failed displays and poor images. FDA records list 5,926 reports, 7 deaths, 54 injuries and 5,865 malfunctions. There are 2 open recalls, about a light guide connector that may lose image or suction, and scope channels returned wet, which could lead to contamination. Reports rose from 597 in the prior 12 months to 3,634 in the latest 12 months.
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
- 5,572
- Deaths reported
- 7
- Injuries reported
- 54
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 5,572 adverse event reports that list this exact device (DI 04953170305290), received between May 10, 2018 and Sep 30, 2026 — classified as 7 deaths, 54 injuries, 5,511 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (1,847 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
- 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-0416-2024 · 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-0334-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Failure to Clean Adequately1,847
- Communication or Transmission Problem816
- No Display/Image666
- Microbial Contamination of Device608
- Device Reprocessing Problem569
- Poor Quality Image526
- Residue After Decontamination344
- Erratic or Intermittent Display133
Patient problems
- No Clinical Signs, Symptoms or Conditions5,293
- No Known Impact Or Consequence To Patient130
- No Consequences Or Impact To Patient59
- Insufficient Information26
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available11
- No Patient Involvement11
- Bacterial Infection10
- Foreign Body In Patient9
Recent adverse event reports
The 25 most recent of 5,572 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 50952755 ↗MalfunctionSep 30, 2026No Display/Image; Residue After Decontamination; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952388 ↗MalfunctionSep 30, 2026Material Protrusion/Extrusion
The customer reported threads protruding out of the distal end during reprocessing involving an Olympus Gastrointestinal Videoscope. There was no patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951345 ↗MalfunctionSep 30, 2026Device Reprocessing Problem
The customer returned the Gastrointestinal videoscope to the service center for a separate issue. During initial investigation of the device foreign objects were found within the light guide lens. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948214 ↗MalfunctionSep 29, 2026Poor Quality Image
The customer reported fuzzy image involving an Olympus Gastrointestinal Videoscope. There was no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936764 ↗MalfunctionSep 29, 2026No Display/Image
The Customer reported disappearance of image during a diagnostic procedure involving an Olympus Gastrointestinal Videoscope. The procedure was completed using the same device. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936697 ↗MalfunctionSep 29, 2026Erratic or Intermittent Display; No Display/Image
The Customer reported image intermittently drops out and flickers involving an Olympus Gastrointestinal Videoscope. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936460 ↗MalfunctionSep 29, 2026Device Reprocessing Problem; Optical Problem
It was reported that the Gastrointestinal Videoscope had a light out. The issue occurred during device setup. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936356 ↗MalfunctionSep 29, 2026Failure to Clean Adequately
The customer returned the gastrointestinal videoscope for a separate issue. During the initial inspection of the device, white residue was found in the air/water channel. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936334 ↗MalfunctionSep 29, 2026Residue After Decontamination
The malfunction reported by the customer during set up was not reportable; it involved an Olympus gastrointestinal videoscope. However, during the initial evaluation of the device, residue on objective lens was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936085 ↗MalfunctionSep 29, 2026Poor Quality Image
The customer reported a blurry image during an endoscopy procedure involving an Olympus Gastrointestinal Videoscope. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936072 ↗MalfunctionSep 29, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935749 ↗MalfunctionSep 29, 2026Erratic or Intermittent Display; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935357 ↗MalfunctionSep 29, 2026Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935007 ↗MalfunctionSep 29, 2026Microbial Contamination of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934748 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component
The customer reported that a white cylinder was found in the instrument channel of the Gastrointestinal Videoscope during reprocessing. No patient involvement reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933725 ↗MalfunctionSep 29, 2026Residue After Decontamination
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933651 ↗MalfunctionSep 29, 2026Residue After Decontamination
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the initial evaluation of the device, the air/water supply channel and cylinder side had white residue. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932925 ↗MalfunctionSep 29, 2026Device Reprocessing Problem
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the initial evaluation of the returned device, the light guide lens had foreign materials. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929933 ↗MalfunctionSep 29, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50927008 ↗MalfunctionSep 28, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924846 ↗MalfunctionSep 28, 2026Residue After Decontamination
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50921241 ↗MalfunctionSep 28, 2026Thermal Decomposition of Device; Residue After Decontamination
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the initial evaluation of the device, it was observed that the distal end cover had a burn mark and the insertion tube had sticky residue. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917876 ↗MalfunctionSep 28, 2026Poor Quality Image; Communication or Transmission Problem
The customer reported the Gastrointestinal Videoscope had a snowy image and scope communication errors during inspection for use. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917703 ↗MalfunctionSep 28, 2026Device Reprocessing Problem
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During device analysis, the service technician identified that the device had foreign material on the C-cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916979 ↗
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- 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
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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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