ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5 (UDI 04953170310355)Recalls & reported problems
Olympus Medical Systems Corp. · LTF-S190-5 ENDOEYE FLEX 5 HD VIDEOSCOPE · Class 2
All models of ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (4)
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 ENDOEYE FLEX deflectable videoscope is a flexible camera scope. Reports most often describe the screen going black or showing no image, and some describe poor image quality. The FDA database lists 1,271 reports, with 19 injuries and no deaths, and reports rose in the last 12 months, to 98 from 42. One recall is open, from November 2023, over reprocessing steps in the instructions that users did not always follow.
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
- 1,279
- Deaths reported
- 0
- Injuries reported
- 19
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,279 adverse event reports that list this exact device (DI 04953170310355), received between Nov 3, 2020 and Sep 30, 2026 — classified as 19 injuries, 1,260 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (798 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
- Nov 20, 2023Class IIOpen, 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 problems
Device problems
- No Display/Image798
- Communication or Transmission Problem211
- Poor Quality Image125
- Erratic or Intermittent Display90
- Display or Visual Feedback Problem71
- Image Display Error/Artifact46
- Detachment of Device or Device Component20
- Break18
Patient problems
- No Clinical Signs, Symptoms or Conditions1,251
- No Patient Involvement8
- Dysphagia/ Odynophagia6
- Fistula5
- Hemorrhage/Blood Loss/Bleeding5
- Insufficient Information4
- Swelling/ Edema2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 1,279 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 50954812 ↗MalfunctionSep 18, 2026No Display/Image; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831148 ↗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 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, 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 ↗MalfunctionAug 4, 2026Erratic or Intermittent Display; Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50128964 ↗MalfunctionJun 25, 2026Material Fragmentation
THE CUSTOMER RETURNED THE DEFLECTABLE VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATED A CHIPPED AND CRACKED OBJECTIVE LENS ADHESIVE. THERE WAS NO PATIENT INVOLVEMENT. ¿
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25621330 ↗MalfunctionJun 10, 2026No Display/Image; Communication or Transmission Problem
THE CUSTOMER REPORTED SOMETIMES AN ERROR MESSAGE APPEARS, AND THE SCREEN TURNS BLACK DURING INSPECTION FOR USE, INVOLVING A ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25465433 ↗MalfunctionJun 8, 2026Image Orientation Incorrect
IT WAS REPORTED THE FLEX DEFLECTABLE VIDEOSCOPE HORIZON ON CAMERA (IMAGE) IS OFF. THE ISSUE WAS FOUND DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428185 ↗MalfunctionJun 2, 2026Display or Visual Feedback Problem
THE CUSTOMER REPORTED THE IMAGE WAS CHANGING COLORS, AND THE SURGEON WAS UNABLE TO SEE DURING A DIAGNOSTIC KIDNEY TRANSPLANT, INVOLVING AN OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE. THE PROCEDURE WAS COMPLETED WITH AN OLYMPUS BACK UP DEVICE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25368808 ↗MalfunctionJun 1, 2026Communication or Transmission Problem
THE CUSTOMER REPORTED ERROR CODE - E216 DISPLAYED DURING AN UNSPECIFIED DIAGNOSTIC PROCEDURE INVOLVING AN OLYMPUS FLEX DEFLECTABLE VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25356139 ↗MalfunctionJun 1, 2026Break
THE FLEX DEFLECTABLE VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, OBJECTIVE LENS GLUE CHIPPED WAS FOUND TO BE MOST LIKELY DUE TO STRESS PROBLEM IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25352708 ↗MalfunctionJun 1, 2026Poor Quality Image
THE FLEX DEFLECTABLE VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF DISTAL TIP IS NOT FLEXING PROPERLY. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, FLICKERING IMAGE WAS FOUND TO BE MOST LIKELY DUE TO ELECTRICAL/ELECTRONIC COMPONENT PROBLEM IDENTIFIED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25351480 ↗MalfunctionJun 1, 2026Communication or Transmission Problem; Connection Problem
IT WAS REPORTED THAT DURING INSPECTION FOR USE, THE VIDEOSCOPE EXPERIENCED A CONNECTION ISSUE, WITH ERROR MESSAGE E215 (SCOPE ERROR) DISPLAYED. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25350082 ↗MalfunctionMay 29, 2026Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE HAD CHIPPED AND PEELING GLUE AROUND THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25335988 ↗MalfunctionMay 26, 2026Display or Visual Feedback Problem
THE FLEX DEFLECTABLE VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH AN UNCLEAR CAMERA. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE IMAGE WAS DISTORTED AND BLOODY AND WAS FOUND TO BE MOST LIKELY DUE TO ELECTRICAL/ELECTRONIC COMPONENT PROBLEM. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25278164 ↗MalfunctionMay 22, 2026No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED THE ONE OF LIGHT GUIDE LENS HAS A TOTAL BLACK OUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256381 ↗MalfunctionMay 22, 2026Material Fragmentation
THE FLEX DEFLECTABLE VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A LEAK. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE OBJECTIVE LENS HAD CHIPPING AND WAS FOUND TO BE MOST LIKELY DUE TO DEGRADATION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25255101 ↗
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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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