GASTROINTESTINAL VIDEOACOPE OLYMPUS GIF-LV1Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
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 GIF-LV1 video scope is a flexible colonoscope used to look inside the digestive tract. Its 67 reports mostly describe cleaning and reprocessing problems, including residue or foreign objects found inside the air/water nozzle and tip, and poor image quality. No deaths and no injuries are reported. One open recall, from September 2023, covers scopes returned after repair whose channel was still wet, which can allow contamination and infection.
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
- 67
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 04953170312373), received between Nov 24, 2021 and May 15, 2025 — classified as 67 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (34 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 Adequately34
- Poor Quality Image15
- Contamination9
- Device Reprocessing Problem7
- Contamination /Decontamination Problem4
- Residue After Decontamination2
- Degraded1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions66
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2025Residue After Decontamination; Residue After Decontamination
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22031666 ↗MalfunctionMay 9, 2025Electrical /Electronic Property Problem; Flare or Flash; Electrical /Electronic Property Problem; Flare or Flash
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD A BURN ON PLASTIC DISTAL END PART AND COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21993427 ↗MalfunctionApr 22, 2025Residue After Decontamination; Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE CONNECTING TUBE AND NOZZLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Insufficient Information
MAUDE report 21886062 ↗MalfunctionOct 2, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED THE BENDING SECTION COVER, NOZZLE AND ADHESIVE AROUND OBJECTIVE LENS HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353466 ↗MalfunctionSep 17, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS WITHIN THE NOZZLE AND DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20239644 ↗MalfunctionSep 12, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIALS WAS EXITING FROM THE AIR/WATER NOZZLE. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM OR PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200890 ↗MalfunctionSep 9, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS ON THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20170870 ↗MalfunctionSep 9, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE NOZZLE OF THE VIDEOSCOPE HAD FOREIGN MATERIAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20168472 ↗MalfunctionSep 4, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE NOZZLE, ADHESIVE ON THE BENDING SECTION COVER (A-RUBBER), AND THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20136933 ↗MalfunctionAug 23, 2024Poor Quality Image; Failure to Clean Adequately; Poor Quality Image; Failure to Clean Adequately
IT WAS REPORTED THE SUBJECT DEVICE HAD AN IMAGE ISSUE. ON SEPTEMBER 2, 2024 THE CUSTOMER CONFIRMED THAT THE IMAGE QUALITY WAS NOT GOOD AND THE IMAGE WAS BLURRED. THE ISSUE OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20050243 ↗MalfunctionJul 8, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE NOZZLE AND BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19688525 ↗MalfunctionJul 2, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THE GASTROINTESTINAL HAS FOREIGN MATTER IN THE CHANNEL TUBE. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A DIAGNOSTIC GASTROSCOPE PROCEDURE. THERE WAS NO DELAY AND THE PROCEDURE WAS COMPLETED BY USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19660896 ↗MalfunctionJun 22, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE NOZZLE AND ADHESIVE ON THE BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19590544 ↗MalfunctionJun 12, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE GASTROINTESTINAL VIDEOSCOPE HAD FOREIGN MATERIALS IN NOZZLE, PLASTIC DISTAL END COVER (C-COVER), ADHESIVE AROUND OBJECTIVE LENS, BENDING SECTION COVER (A-RUBBER), UPWARD/DOWNWARD AND RIGHT/LEFT KNOBS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19522289 ↗MalfunctionJun 10, 2024No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THE GASTROINTESTINAL VIDEOSCOPE HAD A BLURRED IMAGE. THE ISSUE OCCURRED DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19506688 ↗MalfunctionJun 10, 2024Power Problem; Power Problem
PATIENT WAS NOT UNDER ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19500067 ↗MalfunctionMay 7, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A FOREIGN OBJECT ON THE NOZZLE, THE ADHESIVE AROUND OBJECTIVE LENS, THE BENDING SECTION COVER, UP/DOWN KNOB, RIGHT/LEFT KNOB AND THE CONNECTING TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19259853 ↗MalfunctionApr 26, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE NOZZLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19198342 ↗MalfunctionApr 3, 2024Device Reprocessing Problem; Device Reprocessing Problem
DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE NOZZLE, PLASTIC DISTAL END COVER, BENDING SECTION COVER, ADHESIVE AROUND THE OBJECTIVE LENS, CONNECTING TUBE, AND THE UP/DOWN/RIGHT/LEFT KNOBS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19038358 ↗MalfunctionApr 2, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED ADHESIVE AROUND OBJECTIVE LENS HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19029431 ↗MalfunctionMar 20, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING EVALUATION THAT THE NOZZLE AND THE ADHESIVE AROUND OBJECTIVBEL LENS HAD FOREIGN OBJECTS ON THEM. THE BENDING SECTION COVER ALSO HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18944958 ↗MalfunctionMar 19, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOACOPE EXHIBITED ADHESIVE ON BENDING SECTION COVER HAD FOREIGN OBJECTS, CONNECTING TUBE HAD FOREIGN OBJECTS AND BENDING SECTION COVER HAD FOREIGN OBJECTS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18935572 ↗MalfunctionMar 5, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN THE NOZZLE AND IN THE ADHESIVE AROUND THE OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18837254 ↗MalfunctionFeb 1, 2024Difficult to Insert; Failure to Clean Adequately; Difficult to Insert; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE EXHIBITED FOREIGN MATERIAL INSIDE THE CHANNEL BLOCKING BRUSH AND FORCEPS FROM BEING INSERTED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18627947 ↗MalfunctionDec 20, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS, THE GASTROINTESTINAL VIDEOACOPE HAD REDUCED ANGULATION. THE ISSUE WAS FOUND DURING GENERAL ROUTINE INSPECTION. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE BENDING SECTION COVER HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18365652 ↗
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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