ENDOEYE FLEX DEFLECTABLE VIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 3,813
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls
- 2
We found 4 models of ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 3,813 adverse event reports in the FDA's MAUDE database, received between Oct 1, 2020 and Sep 30, 2026 — classified as 28 injuries, 3,785 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (1,654 reports).
2 FDA recall records name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Nov 20, 2023Open, Classified
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
Z-0645-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- Nov 20, 2023Open, Classified
Instructions for Use-User Deviations related to the reprocessing of the videoscope detailed in the Reprocessing Manual Instructions. The steps are required for the proper reprocessing of these videoscopes
Z-0644-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE problems
Device problems
- No Display/Image1,654
- Peeled/Delaminated823
- Communication or Transmission Problem658
- Poor Quality Image518
- Display or Visual Feedback Problem141
- Erratic or Intermittent Display134
- Image Display Error/Artifact108
- Output Problem44
Patient problems
- No Clinical Signs, Symptoms or Conditions3,776
- No Patient Involvement9
- Dysphagia/ Odynophagia6
- Fistula6
- Hemorrhage/Blood Loss/Bleeding5
- Insufficient Information5
- Seroma3
- Necrosis2
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)1 recall1,279 reports
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Ureteroscope and accessories, flexible/rigid1 recall1,125 reports
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Nasopharyngoscope (Flexible Or Rigid)785 reports
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5Laparoscope, Gynecologic (And Accessories)624 reports
Recent ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE adverse event reports
The 15 most recent reports across all models, 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 50954812 ↗MalfunctionSep 18, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831148 ↗MalfunctionSep 18, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830180 ↗MalfunctionSep 18, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829425 ↗MalfunctionSep 15, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781514 ↗MalfunctionSep 15, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50778917 ↗MalfunctionSep 10, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716608 ↗MalfunctionSep 8, 2026Optical Problem
The customer returned the Flex Deflectable Videoscope for a separate issue. During the device analysis, the image was flickering when angulating the angulation lever. There was no patient involvement, and no harm was reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50663813 ↗MalfunctionSep 2, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50571347 ↗MalfunctionSep 1, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547718 ↗MalfunctionAug 27, 2026No Display/Image
It was reported that when articulating the head of the flex deflectable videoscope during an unknown diagnostic procedure, the screen was blacking out. The procedure was completed with a back-up device. There was no report of patient injury or adverse patient effects.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50482821 ↗MalfunctionAug 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421884 ↗MalfunctionAug 11, 2026Poor Quality Image; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210153 ↗MalfunctionAug 11, 2026Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50204881 ↗MalfunctionAug 5, 2026Communication or Transmission Problem; Output Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50147708 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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