ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-10-3D (UDI 04953170340710)Recalls & reported problems
Olympus Medical Systems Corp. · Class 2
All models of ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus ENDOEYE FLEX 3D videoscope is a bendable scope used for viewing inside the body during surgery. Many of the 292 reports describe the image failing or looking blurry, adhesive peeling off the lens, and damage at the tip. The number of reports rose from 19 in the prior 12 months to 36 in the last 12 months. The reports include no deaths and 17 injuries. No recalls name this device.
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
- 293
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 293 adverse event reports that list this exact device (DI 04953170340710), received between Apr 8, 2020 and Sep 9, 2026 — classified as 17 injuries, 276 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (68 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
- No Display/Image68
- Peeled/Delaminated65
- Communication or Transmission Problem32
- Poor Quality Image29
- Degraded23
- Adverse Event Without Identified Device or Use Problem16
- Break14
- Detachment of Device or Device Component13
Patient problems
- No Clinical Signs, Symptoms or Conditions275
- Hemorrhage/Blood Loss/Bleeding5
- Fistula4
- Wound Dehiscence3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Obstruction/Occlusion2
- Post Operative Wound Infection2
- Thrombosis/Thrombus2
Recent adverse event reports
The 25 most recent of 293 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50694859 ↗MalfunctionAug 26, 2026Degraded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50457014 ↗MalfunctionAug 5, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50147516 ↗MalfunctionJun 25, 2026Detachment of Device or Device Component
THE CUSTOMER RETURNED THE FLEX DEFLECTABLE VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT THE ADHESIVE ON THE OBJECTIVE LENS IS CHIPPED AND PARTIALLY MISSING, AND THE BENDING SECTION COVER GLUE IS CHIPPED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25629762 ↗MalfunctionJun 25, 2026Peeled/Delaminated
THE CUSTOMER RETURNED THE FLEX DEFLECTABLE VIDEOSCOPE TO THE SERVICE CENTER FOR A SEPARATE ISSUE. DURING THE DEVICE ANALYSIS, THE SERVICE REPAIR TECHNICIAN INDICATES THAT THE OBJECTIVE LENS CEMENT WAS PEELING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25620501 ↗MalfunctionJun 9, 2026Break; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25448516 ↗MalfunctionJun 2, 2026Degraded
IT WAS REPORTED THAT DURING IN-ROOM SET UP / INSPECTION FOR AN UNSPECIFIED PROCEDURE, PRIOR TO THE PATIENT BEING IN THE ROOM, THE FLEX DEFLECTABLE VIDEOSCOPE WAS FOUND TO EXHIBIT DAMAGE AT THE DEVICE TIP. 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 25359240 ↗MalfunctionApr 23, 2026Break; Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX 3D DEFLECTABLE VIDEOSCOPE HAD ADHESIVE DETACHED FROM THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24962089 ↗MalfunctionApr 21, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE VIDEOSCOPE HAD CHIPPED A-RUBBER AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24942606 ↗MalfunctionApr 15, 2026Degraded; Material Fragmentation
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE 3D VIDEOSCOPE EXHIBITED THE OBJECTIVE LENS GLUE WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887999 ↗MalfunctionApr 14, 2026Material Integrity Problem; Sharp Edges
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24868068 ↗MalfunctionApr 6, 2026Material Split, Cut or Torn
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ADHESIVE ON THE VIDEOSCOPE'S DISTAL END HAD A HOLE AND ITS BENDING SECTION COVER ADHESIVE WAS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24792202 ↗MalfunctionMar 19, 2026Dent in Material; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX 3D DEFLECTABLE VIDEOSCOPE EXHIBITED A DENT AT THE DISTAL BODY AND PEELING CEMENT IN THE LIGHT GUIDE AND OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24643185 ↗MalfunctionFeb 5, 2026Break
IT WAS REPORTED THE DURING REPROCESSING, THE FLEX 3D DEFLECTABLE VIDEOSCOPE EXHIBITED A BROKEN DISTAL TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24268550 ↗MalfunctionFeb 5, 2026Material Separation
IT WAS OBSERVED DURING THE DEVICE INVESTIGATION THAT THE FLEX DEFLECTABLE VIDEOSCOPE HAD A MISSING ADHESIVE ON THE DISTAL END OF THE BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24267497 ↗MalfunctionFeb 3, 2026Material Puncture/Hole
NO ADDITIONAL INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24251197 ↗MalfunctionFeb 2, 2026Material Split, Cut or Torn
NO ADDITIONAL INFORMATION REC FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24235474 ↗MalfunctionJan 30, 2026Peeled/Delaminated; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX 3D DEFLECTABLE VIDEOSCOPE EXHIBITED PEELING CEMENT AROUND THE ADHESIVE AT THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24220312 ↗MalfunctionJan 28, 2026Material Split, Cut or Torn
NO ADDITIONAL INFORMATION REPORTED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24206555 ↗MalfunctionJan 22, 2026Poor Quality Image
IT WAS REPORTED THE FLEX 3D DEFLECTABLE VIDEOSCOPE PRESENTED A VERY DIM LIGHT. THE ISSUE WAS IDENTIFIED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24147986 ↗MalfunctionJan 22, 2026Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX 3D DEFLECTABLE VIDEOSCOPE LIGHT GUIDE PRONG AND MOUNT WAS MISSING THE CHANNEL RING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24144972 ↗MalfunctionJan 21, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED THE VIDEOSCOPE EXHIBITED TORN DISTAL TIP. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24141228 ↗MalfunctionJan 21, 2026Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX 3D DEFLECTABLE VIDEOSCOPE HAD A DIRTY OBJECT LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24132223 ↗MalfunctionJan 9, 2026Poor Quality Image; Material Integrity Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX 3D DEFLECTABLE VIDEOSCOPE HAD A LINE IN THE IMAGE AND CRACKED A-RUBBER AT THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24027819 ↗MalfunctionJan 9, 2026Degraded; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX 3D DEFLECTABLE VIDEOSCOPE HAD AN UNEVEN SEAL AT THE SEAM ON THE DISTAL END AND PEELING CEMENT AROUND THE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24027394 ↗
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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
- 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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