ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10 (UDI 04953170310386)Recalls & reported problems
Olympus Medical Systems Corp. · LTF-S190-10 ENDOEYE FLEX 10 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 videoscope is a flexible camera used to look inside the body during procedures. Of its 1,123 reports, 6 describe injuries and 1,117 describe malfunctions, with no deaths. Many reports describe a blank display, poor or foggy images, and glue around the lens chipping off. Reports rose to 23 in the last 12 months from 10 in the previous 12 months. 1 open recall, started in November 2023, concerns users not following the reprocessing steps in the instructions.
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
- 1,125
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1,125 adverse event reports that list this exact device (DI 04953170310386), received between Oct 1, 2020 and Sep 18, 2026 — classified as 6 injuries, 1,119 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (434 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-0645-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported problems
Device problems
- Peeled/Delaminated434
- No Display/Image312
- Communication or Transmission Problem189
- Poor Quality Image168
- Display or Visual Feedback Problem49
- Image Display Error/Artifact44
- Erratic or Intermittent Display17
- Signal Artifact/Noise12
Patient problems
- No Clinical Signs, Symptoms or Conditions1,116
- No Consequences Or Impact To Patient2
- Seroma2
- Abdominal Pain1
- Electric Shock1
- Fever1
- Fistula1
- Hernia1
Recent adverse event reports
The 25 most recent of 1,125 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50830180 ↗MalfunctionSep 10, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716608 ↗MalfunctionAug 11, 2026Poor Quality Image; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210153 ↗MalfunctionAug 5, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142078 ↗MalfunctionJun 8, 2026Poor Quality Image
THE CUSTOMER REPORTED SCOPE IS NOT PROVIDING CLEAR PICTURE, VERY FOGGY, INVOLVING AN OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25438506 ↗MalfunctionMay 22, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED THE CEMENT AROUND LENS IS CHIPPING OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25256453 ↗MalfunctionMay 20, 2026Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED THE IMAGE FREEZE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25230585 ↗MalfunctionMay 18, 2026Poor Quality Image
THE CUSTOMER REPORTED A GREEN TINT TO IMAGE DURING PREPARATION FOR USE, INVOLVING AN OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25209292 ↗MalfunctionMay 15, 2026Dent in Material
THE FLEX DEFLECTABLE VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED MANUAL LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT, HOWEVER, A REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, A DENT ON THE DISTAL TIP WAS FOUND, LIKELY DUE TO STRESS. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25183381 ↗MalfunctionMay 7, 2026Poor Quality Image
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, A REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE IMAGE WAS FOUND TO BE DISTORTED, LIKELY DUE TO COMPONENT FAILURE. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25112401 ↗MalfunctionApr 28, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED A CHIPPED GLUE AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25023785 ↗MalfunctionApr 15, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED GREEN IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885160 ↗MalfunctionApr 14, 2026Erratic or Intermittent Display
IT WAS REPORTED THAT THE ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE HAD A GRAINY IMAGE. THE ISSUE OCCURRED DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24879921 ↗MalfunctionApr 13, 2026Display or Visual Feedback Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24856949 ↗MalfunctionApr 3, 2026Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE VIDEOSCOPE HAD A DENT ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24778440 ↗MalfunctionApr 1, 2026No Display/Image; Peeled/Delaminated; Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED PEELING GLUE AT THE OBJECTIVE LENS AND A BLACK IMAGE WITH A SCOPE COMMUNICATION ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24760917 ↗MalfunctionApr 1, 2026Poor Quality Image
IT WAS REPORTED THE VIDEOSCOPE EXHIBITED DISTORTED PICTURE. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758072 ↗MalfunctionMar 19, 2026Break
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24635922 ↗MalfunctionMar 13, 2026Material Deformation
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24599458 ↗MalfunctionFeb 27, 2026Corroded; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED INTERMITTENT IMAGE AND RUST WAS AROUND THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24469735 ↗MalfunctionJan 16, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE VIDEOSCOPE HAD A DIRTY OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093232 ↗MalfunctionJan 2, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE VIDEOSCOPE HAD LINES IN THE IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23945680 ↗MalfunctionDec 17, 2025Degraded; Degraded
IT WAS REPORTED THE VIDEOSCOPE EXHIBITED DAMAGE AT THE DISTAL END, THE RUBBER SHEATH WAS TORN. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23835314 ↗MalfunctionDec 16, 2025Unexpected Color; Unexpected Color
IT WAS REPORTED THAT THE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED INTERMITTENT COLOR CHANGES TO VIOLET, THEN FLASHES BETWEEN VIOLET AND NORMAL COLOR. THE ISSUE OCCURRED DURING SET UP / INSPECTION PRIOR TO USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23821516 ↗MalfunctionDec 12, 2025Material Deformation; Material Deformation
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23796875 ↗
Other Ureteroscope and accessories, flexible/rigid devices
- URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls397 reports
- URETERO-RENO VIDEOSCOPE OLYMPUS URF-V2ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall305 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls190 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P6Olympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid2 recalls170 reports
- ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-10-3DOlympus Medical Systems Corp. · Ureteroscope And Accessories, Flexible/Rigid186 reports
- URETERO-RENO FIBERSCOPE OLYMPUS URF-P7ROlympus Medical Systems Corp. · Ureteroscope and accessories, flexible/rigid1 recall121 reports
- n.a. 091279-01Karl Storz GmbH & Co. KG · Ureteroscope and accessories, flexible/rigid118 reports
- Flex-X / IMAGE 1 S 11278VSUAKarl Storz GmbH & Co. KG · Ureteroscope and accessories, flexible/rigid2 recalls2 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.
How reports and recalls are matched · Editorial policy · Report an error on this page