ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 479
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls
- 0
We found 2 models of ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 479 adverse event reports in the FDA's MAUDE database, received between Apr 8, 2020 and Sep 9, 2026 — classified as 17 injuries, 462 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (126 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. 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
Most reported ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE problems
Device problems
- Peeled/Delaminated126
- No Display/Image112
- Communication or Transmission Problem64
- Poor Quality Image55
- Degraded40
- Break19
- Adverse Event Without Identified Device or Use Problem16
- Detachment of Device or Device Component15
Patient problems
- No Clinical Signs, Symptoms or Conditions460
- Hemorrhage/Blood Loss/Bleeding5
- Fistula4
- Wound Dehiscence3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- No Patient Involvement2
- Obstruction/Occlusion2
- Post Operative Wound Infection2
ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-10-3DLaparoscope, general & plastic surgery293 reports
- ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-190-10-3DUreteroscope And Accessories, Flexible/Rigid186 reports
Recent ENDOEYE FLEX 3D 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 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 ↗
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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