GASTROINTESTINAL VIDEOSCOPE GIF-Q150 (UDI 04953170307485)Recalls & 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 gastrointestinal videoscope has 342 adverse event reports on file, with no deaths and no injuries. Many reports describe the scope not being cleaned fully, poor image quality, and residue left after cleaning. 1 open recall names this device: it began in September 2023 and concerns a drying step that was not validated, which may leave water in the channel and raise the risk of infection. Reports in the last 12 months rose to 195 from 62 in the prior 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
- 330
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 330 adverse event reports that list this exact device (DI 04953170307485), received between Sep 2, 2020 and Sep 30, 2026 — classified as 330 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (107 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
- 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 Adequately107
- Poor Quality Image90
- Residue After Decontamination27
- Device Reprocessing Problem24
- Break17
- No Display/Image17
- Erratic or Intermittent Display16
- Contamination11
Patient problems
- No Clinical Signs, Symptoms or Conditions327
- No Consequences Or Impact To Patient2
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 330 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954922 ↗MalfunctionSep 30, 2026Failure to Clean Adequately
The customer returned the gastrointestinal videoscope for a separate issue. During the initial evaluation of the returned device, the protector of the universal cord on the control section side was observed to be sticky. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951145 ↗MalfunctionSep 30, 2026Erratic or Intermittent Display; No Display/Image; Poor Quality Image
The customer returned the gastrointestinal videoscope to the service center for a separate issue. During the device analysis no image was displayed, and image noise and disturbance was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945774 ↗MalfunctionSep 25, 2026Failure to Clean Adequately
The customer returned the gastrointestinal videoscope to the service center for a separate issue. During device analysis, the service repair technician observed that the connecting tube and the universal cord were sticky. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900277 ↗MalfunctionSep 25, 2026Break; Poor Quality Image
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During the device analysis, the service team indicated damage on the charged coupled device (CCD) unit was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50895486 ↗MalfunctionSep 24, 2026Break; Corroded; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888995 ↗MalfunctionSep 23, 2026Poor Quality Image; Optical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873809 ↗MalfunctionSep 23, 2026Break
The customer reported the gastrointestinal videoscope had a separate issue. During the initial evaluation of the device, it was observed that the specified resolving power was not obtained due to damage on charged coupled device unit. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870953 ↗MalfunctionSep 21, 2026Poor Quality Image
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During device analysis, the service repair technician observed the noisy image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50841903 ↗MalfunctionSep 17, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50810234 ↗MalfunctionSep 2, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50572382 ↗MalfunctionSep 2, 2026Poor Quality Image; Failure to Clean Adequately
No additional information received from customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564008 ↗MalfunctionAug 25, 2026Display or Visual Feedback Problem; Misfocusing
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50438535 ↗MalfunctionAug 14, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50256381 ↗MalfunctionAug 13, 2026Misfocusing; Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50239307 ↗MalfunctionJul 7, 2026Material Deformation
THE CUSTOMER REPORTED KINKS IN THE INSERTION TUBE DURING INSPECTION FOR USE INVOLVING AN OLYMPUS GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25739201 ↗MalfunctionJun 30, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TECHNICIAN INDICATED THAT A STICKY UNIVERSAL CORD WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25673819 ↗MalfunctionJun 30, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES FOREIGN OBJECTS IN THE NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25666954 ↗MalfunctionJun 29, 2026Poor Quality Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING DEVICE ANALYSIS, THE SERVICE TEAM INDICATED THAT THE SPECIFIED RESOLVING POWER WAS NOT OBTAINED DUE TO DAMAGE TO THE CHARGE COUPLED DEVICE (CCD UNIT). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25657125 ↗MalfunctionJun 26, 2026Corroded; Decrease in Suction; Difficult or Delayed Positioning; Positioning Failure; Material Discolored; Peeled/Delaminated; Dent in Material; Gas/Air Leak; Improper Flow or Infusion; Scratched Material
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TECHNICIAN INDICATED THAT STICKY CONNECTING TUBE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25644637 ↗MalfunctionJun 26, 2026Degraded; Poor Quality Image; Failure to Clean Adequately
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR SEPARATE ISSUES. DURING THE DEVICE ANALYSIS, THE SERVICE CENTER INDICATES THAT UNIVERSAL CORD IS STICKY, DAMAGE ON CHARGED COUPLED DEVICE (CCD) UNIT, THE SPECIFIED RESOLVING POWER IS NOT OBTAINED, AND A BLURRY IMAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25641085 ↗MalfunctionJun 25, 2026Melted; Physical Resistance/Sticking
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE TECHNICIAN INDICATED THAT A STICKY UNIVERSAL CORD AND A BURN ON THE C-COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25631273 ↗MalfunctionJun 25, 2026Degraded; Residue After Decontamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE INVESTIGATION INDICATES THAT FOREIGN OBJECTS IN THE NOZZLE, STICKY CONNECTING TUBE, STICKY IMAGE GUIDE PROTECTOR AND DAMAGED ON CHARGED COUPLED DEVICE UNIT RESULTING IN SPECIFIED POWER TO NOT BE OBTAINED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25623026 ↗MalfunctionJun 24, 2026Flare or Flash
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE , THE INVESTIGATION INDICATES THAT BURN ON THE C-COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25610578 ↗MalfunctionJun 22, 2026Residue After Decontamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES FOREIGN MATERIAL FROM THE SUCTION CYLINDER, THERE WAS NOT PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25588062 ↗
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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
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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