ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5 (REF N3828033)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This is an Olympus ENDOEYE FLEX deflectable videoscope used in gynecologic laparoscopy. The 624 reports mostly describe no image or a black screen, flickering, or poor image quality, with some noting image noise and transmission problems. There are 2 injuries and no deaths. No recalls name this device. There were no reports in the last 12 months, down from 46 in the 12 months 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
- 624
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 624 adverse event reports that list this exact device (DI 04953170434648), received between May 4, 2023 and Jul 9, 2025 — classified as 2 injuries, 622 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (384 reports).
1 other recall cover devices cleared under the same FDA submission (K201832); they may or may not involve this specific model.
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
- No Display/Image384
- Communication or Transmission Problem151
- Poor Quality Image78
- Erratic or Intermittent Display18
- Output Problem16
- Display or Visual Feedback Problem10
- Noise, Audible10
- Image Display Error/Artifact9
Patient problems
- No Clinical Signs, Symptoms or Conditions624
Recent adverse event reports
The 25 most recent of 624 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2025No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT DURING SERVICE / MAINTENANCE, THE FLEX DEFLECTABLE VIDEOSCOPE HAD IMAGE NOISE AND NO IMAGE WHEN OPERATING THE ANGLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459105 ↗MalfunctionMar 7, 2025No Display/Image; No Display/Image
IT WAS REPORTED THE VIDEOSCOPE WAS NOT DISPLAYING AN IMAGE ON THE MONITOR DURING A LOW ANTERIOR RESECTION PROCEDURE. THE EVENT DID NOT RESULT IN ANY DELAY TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21544298 ↗MalfunctionFeb 26, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED SCREEN WAS COMPLETELY BLACK AND NO IMAGE WAS DISPLAYED DUE TO DAMAGE TO THE IMAGING SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21473592 ↗MalfunctionFeb 25, 2025Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT DURING A THERAPEUTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, OUTSIDE OF THE SEDATED PATIENT, THE SUBJECT FLEX VIDEO SCOPE DEVICE HAD A GREEN DOT APPEAR ON THE RIGHT SIDE OF THE IMAGE. THERE WAS NO HARM ON INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21463348 ↗MalfunctionFeb 23, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21442079 ↗MalfunctionFeb 10, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT WHEN THE DEVICE WAS ANGULATED, IT CAUSED A BLACKOUT OF THE IMAGE. THE ISSUE OCCURRED DURING AN UNKNOWN THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21350567 ↗MalfunctionJan 17, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
IT WAS REPORTED THAT THE SUBJECT DEVICE'S IMAGE WAS FLICKERING. THE ISSUE WAS FOUND DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21181149 ↗MalfunctionJan 16, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21172678 ↗MalfunctionJan 16, 2025No Display/Image; No Display/Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21169520 ↗MalfunctionJan 14, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SUBJECTED DEVICE DISPLAYED NO IMAGE. THE ISSUE WAS FOUND DURING SETUP OR INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21149901 ↗MalfunctionDec 29, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING SET UP THE SUBJECT DEVICE ENCOUNTERED SCOPE COMMUNICATION ERROR, E216 DURING SETUP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032567 ↗MalfunctionDec 11, 2024Poor Quality Image; Communication or Transmission Problem; Poor Quality Image; Communication or Transmission Problem
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20900816 ↗MalfunctionDec 10, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE FLEX DEFLECTABLE VIDEOSCOPE HAD A COMMUNICATION ERROR. THE ISSUE OCCURRED DURING SETUP/INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20889233 ↗MalfunctionDec 9, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT WHILE USING THE FLEX VIDEO SCOPE AN IMAGE WAS NOT DISPLAYED. THE REPORTED MALFUNCTION OCCURRED DURING SETUP AND INSPECTION FOR USE PRIOR TO AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20879184 ↗MalfunctionDec 6, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT, DURING AN UNKNOWN THERAPEUTIC PROCEDURE, THE SUBJECT DEVICE PRODUCED AN IMAGE WHICH WAS COMPLETELY BLACK, AND THE TARGET COULD NOT BE VISUALIZED. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT OLYMPUS DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20871529 ↗MalfunctionDec 3, 2024No Display/Image; Communication or Transmission Problem; No Display/Image; Communication or Transmission Problem
IT WAS REPORTED THE FLEX DEFLECTABLE VIDEOSCOPE HAD AN E218 SCOPE ERROR, AS WELL AS AN IMAGE CUTOFF. THE ISSUE OCCURRED DURING INSTALLATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835563 ↗MalfunctionNov 27, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE, NO IMAGE WAS DISPLAYED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20801065 ↗MalfunctionNov 27, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE FLEX VIDEO SCOPE HAD A DISTORTED IMAGE AND CANNOT BE SEEN. THE REPORTED MALFUNCTION OCCURRED SETUP AND INSPECTION FOR USE PRIOR TO AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20793732 ↗MalfunctionNov 25, 2024Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED, THE FLEX DEFLECTABLE VIDEOSCOPE'S FLEX TIP WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773723 ↗MalfunctionNov 25, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THE FLEX DEFLECTABLE VIDEOSCOPE HAD POOR IMAGE QUALITY. THE ISSUE OCCURRED DURING SETUP/INSPECTION FOR USE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20772384 ↗MalfunctionNov 24, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE THE SUBJECT DEVICE HAD POOR IMAGE QUALITY. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20767601 ↗MalfunctionNov 24, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT THE SUBJECT DEVICE DISPLAYED AN E126 ERROR DURING SET UP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20767250 ↗MalfunctionNov 24, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE SUBJECT DEVICE PRESENTED NOISE WHEN ANGULATION WAS APPLIED. THE ISSUE OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20767160 ↗MalfunctionNov 24, 2024No Display/Image; No Display/Image
IT WAS REPORTED THE SUBJECT FLEX VIDEO SCOPE IMAGE DID NOT APPEAR. THE ISSUE OCCURRED WHEN PREPARING THE DEVICE FOR USE. THERE WAS NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20767155 ↗MalfunctionNov 23, 2024Communication or Transmission Problem; Communication or Transmission Problem
NO NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20766456 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K201832. One submission often covers many models, so check the product and lot details in each record.
- Z-0644-2024 · Nov 20, 2023 · Open, ClassifiedOLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments
Other Laparoscope, Gynecologic (And Accessories) devices
- Olympus WA50042AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)1 recall6,135 reports
- Olympus WA50052AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)2,249 reports
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-5Olympus Medical Systems Corp. · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)1 recall1,279 reports
- Olympus WA50040AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)1 recall954 reports
- Olympus WA50050AOLYMPUS Winter & Ibe GmbH · Laparoscope, Gynecologic (And Accessories)895 reports
- Epix Laparoscopic Scissors CB030Applied Medical Resources Corporation · Laparoscope, Gynecologic (And Accessories)239 reports
- HD EndoEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VHOlympus Medical Systems Corp. · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)168 reports
- AHTO 0250070620Stryker Corporation · LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)2 recalls59 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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