GASTROINTESTINAL VIDEOSCOPE GIF-Q150 (UDI 04953170229435)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
Quick summary
This Olympus gastrointestinal videoscope is an endoscope used to look inside the digestive tract. The 285 reports often describe scopes that were not cleaned adequately during reprocessing, poor image quality, and scopes that showed no image. The reports include no deaths and 1 injury. No recalls name this device, and reports rose to 60 in the last year from 18 in the year before.
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
- 283
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 283 adverse event reports that list this exact device (DI 04953170229435), received between Aug 8, 2019 and Sep 10, 2026 — classified as 1 injury, 282 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (130 reports).
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 Adequately130
- Poor Quality Image85
- Device Reprocessing Problem24
- Contamination15
- No Display/Image11
- Contamination /Decontamination Problem6
- Corroded6
- Device Contamination with Chemical or Other Material5
Patient problems
- No Clinical Signs, Symptoms or Conditions278
- Insufficient Information2
- Injury1
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 283 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Thermal Decomposition of Device
The customer returned the Gastrointestinal Videoscope for a separate issue. During the initial evaluation of the device it was observed, a burn on the terminal cover. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50711746 ↗MalfunctionAug 26, 2026No Apparent Adverse Event
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456196 ↗MalfunctionAug 12, 2026Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223968 ↗MalfunctionJul 10, 2026Poor Quality Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES A BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25783473 ↗MalfunctionJun 26, 2026Material Discolored
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE, WHICH IS AN OLYMPUS ASSET, WITH NO REPORTED COMPLAINT. HOWEVER, DURING THE EVALUATION OF THE DEVICE, A PROTECTOR OF THE UNIVERSAL CORD ON THE SCOPE CONNECTOR (S-CONNECTOR) SIDE WAS STICKY. THE SERVICE REPAIR TECHNICIAN ASSESSED THE CONDITION BUT COULD NOT DETERMINE THE CAUSE OF THE FAILURE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25638306 ↗MalfunctionJun 3, 2026Poor Quality Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE CENTER IDENTIFIED THAT THE DEVICE HAD A BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25376618 ↗MalfunctionMay 31, 2026Overheating of Device
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING EVALUATION OF THE DEVICE THE DEVICE WAS FOUND TO HAVE BURNT C-COVER. THE SERVICE REPAIR TECHNICIAN INDICATED IT IS POSSIBLE THAT HIGH-ENERGY INSTRUMENTS (SUCH AS HIGH-FREQUENCY DEVICES) WERE USED WITHOUT MAINTAINING SUFFICIENT DISTANCE FROM THE TIP CAUSING BURNT C-COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25342410 ↗MalfunctionMay 31, 2026Poor Quality Image
THE CUSTOMER REPORTED ARTIFACTS IN THE IMAGE DURING REPROCESSING INVOLVING AN OLYMPUS GASTROINTESTINAL VIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25341129 ↗MalfunctionApr 22, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE LIGHT GUIDE COVER LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24956265 ↗MalfunctionApr 15, 2026Material Discolored; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE'S INSIDE OF THE LIGHT GUIDE LENS HAD DISCOLORATION AND THE IMAGE WAS NOT DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885832 ↗MalfunctionApr 14, 2026Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE HAD EXCESSIVE DIRT ON THE DISTAL TIP COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24874281 ↗MalfunctionApr 13, 2026No Display/Image; Melted
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A BURN MARK ON THE TERMINAL COVER AND A MISSING ENDOSCOPIC IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24855895 ↗MalfunctionApr 11, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE'S AIR WATER-CYLINDER AND NOZZLE HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24852268 ↗MalfunctionApr 10, 2026Corroded
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE GASTROINTESTINAL VIDEOSCOPE OBJECTIVE LENS HAD A CORROSION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24840364 ↗MalfunctionApr 9, 2026Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED A SCOPE COMMUNICATION B30 ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24833496 ↗MalfunctionApr 8, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED FOREIGN MATERIAL CAME OUT OF THE SUCTION CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24821077 ↗MalfunctionApr 8, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE PRESENTED BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24817540 ↗MalfunctionApr 7, 2026Melted; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD BLURRY IMAGE AND BURN ON LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24798416 ↗MalfunctionApr 6, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THE GASTROINTESTINAL VIDEOSCOPE HAD AN INSTANCE OF NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24795834 ↗MalfunctionApr 6, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED CORROSION IN THE DIFFUSER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792842 ↗MalfunctionApr 6, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD CORRODED SUCTION CYLINDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24788020 ↗MalfunctionApr 3, 2026Material Protrusion/Extrusion
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED INSERTION TUBE HAD PROTRUSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24782352 ↗MalfunctionMar 31, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED NOZZLE HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24748539 ↗MalfunctionMar 31, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE HAD CORROSION ON INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742827 ↗MalfunctionMar 31, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE GASTROINTESTINAL VIDEOSCOPE EXHIBITED STICKY GRIP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24739213 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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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