ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10 (REF N3828133)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 Olympus ENDOEYE Flex videoscope has 785 FDA reports, including 784 malfunctions, 1 injury and no deaths. Many reports describe the outer adhesive peeling off the tip, the screen showing no image or poor image quality, and communication errors during setup or service. There are no recalls naming this device. Reports fell from 26 in the previous 12 months to 0 in the most recent 12 months.
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
- 785
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 785 adverse event reports that list this exact device (DI 04953170434662), received between Apr 6, 2021 and Mar 19, 2025 — classified as 1 injury, 784 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (382 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
- Peeled/Delaminated382
- No Display/Image160
- Poor Quality Image147
- Communication or Transmission Problem107
- Display or Visual Feedback Problem11
- Erratic or Intermittent Display9
- Image Display Error/Artifact9
- Output Problem9
Patient problems
- No Clinical Signs, Symptoms or Conditions785
Recent adverse event reports
The 25 most recent of 785 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2025No Device Output; Communication or Transmission Problem; No Device Output; Communication or Transmission Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED A B31 (SCOPE COMMUNICATION ERROR) DUE TO DAMAGE TO THE IMAGING UNIT AND THE SCOPE ID DATA WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21640913 ↗MalfunctionMar 11, 2025No Display/Image; Connection Problem; No Display/Image; Connection Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX VIDEO SCOPE EXHIBITED NO IMAGE WAS DISPLAYED AND AN E216 (SCOPE COMMUNICATION ERROR). THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21570937 ↗MalfunctionFeb 21, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING SERVICE / MAINTENANCE, THE FLEX VIDEO SCOPE DEVICE DISPLAYED AN UNKNOWN ERROR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21434771 ↗MalfunctionFeb 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THAT THE SUBJECT DEVICE HAD ADHESIVE PEELING AT DISTAL END DURING SETUP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21367760 ↗MalfunctionJan 22, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED DURING SET UP / INSPECTION FOR USE, THE SUBJECT DEVICE RUBBER ADHESIVE PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21208628 ↗MalfunctionJan 15, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING SET UP, THE SUBJECT FLEX VIDEO SCOPE DEVICE HAD A COMMUNICATION ERROR OCCUR, COLOR BAR DISPLAYED AND THEN SANDSTORM OCCURRED. THERE WAS REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21158239 ↗MalfunctionJan 8, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE SCOPE HAD ABNORMAL IMAGE. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21103740 ↗MalfunctionJan 6, 2025No Display/Image; No Display/Image
IT WAS REPORTED THAT THE FLEX DEFLECTABLE VIDEOSCOPE'S IMAGE WAS NOT SHOWING. THE ISSUE OCCURRED DURING SETUP/INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078931 ↗MalfunctionDec 9, 2024Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20884725 ↗MalfunctionDec 6, 2024Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20865289 ↗MalfunctionDec 6, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT WHILE USING THE SUBJECT DEVICE, THE VIDEO IMAGE DID NOT APPEAR AND THERE WAS A BLACKOUT. THE REPORTED MALFUNCTION OCCURRED DURING SETUP PRIOR TO AN UNSPECIFIED THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20859862 ↗MalfunctionDec 5, 2024Break; Break
IT WAS REPORTED THAT THE SUBJECT DEVICE'S BENDING SECTION COVER'S ADHESIVE PART WAS MISSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20852831 ↗MalfunctionDec 4, 2024No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE SUBJECT DEVICE PRESENTED POOR IMAGE QUALITY AND THEN NO IMAGE. THE PROCEDURE WAS COMPLETED UTILIZING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20846151 ↗MalfunctionDec 3, 2024Poor Quality Image; Poor Quality Image
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20837093 ↗MalfunctionDec 3, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE SUBJECT DEVICE SHOWED THE E218 ERROR CODE, IT OCCURRED EVEN AFTER RECONNECTION. THE ISSUE OCCURRED DURING SET UP. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835950 ↗MalfunctionNov 27, 2024Unintended Power Up; Unintended Power Up
IT WAS REPORTED THAT DURING THE PRE-USE INSPECTION, THE SUBJECT FLEX VIDEO SCOPE DEVICE REMOTE SWITCH WOULD REACT UNINTENTIONALLY. THERE WAS NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20798078 ↗MalfunctionNov 27, 2024No Display/Image; No Display/Image
IT WAS REPORTED DURING THE PRE-USE INSPECTION, THE SUBJECT FLEX VIDEO SCOPE HAD A MALFUNCTION OF NO IMAGE DISPLAYED. THERE WAS NO HARM OR INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20792538 ↗MalfunctionNov 25, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THE FLEX DEFLECTABLE VIDEOSCOPE HAD A RUBBER PINHOLE. THE ISSUE OCCURRED DURING SERVICE/MAINTENANCE, NOT IN A CLINICAL SETTING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20770813 ↗MalfunctionNov 22, 2024Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS REPORTED THE ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE HAD A RUBBER ADHESIVE CHIPPING. THE ISSUE WAS FOUND DURING SERVICING AND MAINTENANCE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20763020 ↗MalfunctionNov 22, 2024Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THE FLEX DEFLECTABLE VIDEOSCOPE HAD A B30 SCOPE COMMUNICATION ERROR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759111 ↗MalfunctionNov 18, 2024No Display/Image; No Display/Image
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ENDOEYE DEFLECTABLE VIDEOSCOPE EXHIBITED THE IMAGE WAS NOT DISPLAYED DUE TO DAMAGE ON CHARGED COUPLED DEVICE UNIT. IN ADDITION, NO IMAGE WAS DISPLAYED DUE TO WEAR ON THE ELECTRICAL CONTACTS OF THE VIDEO CONNECTOR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20710841 ↗MalfunctionNov 12, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED TIP OBJECTIVE LENS ADHESIVE PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20665390 ↗MalfunctionNov 11, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEX DEFLECTABLE VIDEOSCOPE EXHIBITED PEELING OF THE ADHESIVE PART OF OBJECTIVE LENS IN TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20658360 ↗MalfunctionNov 8, 2024Break; Communication or Transmission Problem; Break; Communication or Transmission Problem
IT WAS REPORTED, THE DEFLECTABLE VIDEOSCOPE EXHIBITED TIP IMAGE B30 (SCOPE COMMUNICATION) ERROR, AND HAD A CONNECTOR ID FUNCTION MALFUNCTION. THE ISSUE OCCURRED DURING A THERAPEUTIC PROCEDURE FOR A DIGESTIVE SURGERY. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAY, PATIENT HARM, INJURY, OR DEATH. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20637666 ↗MalfunctionNov 7, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE ENDOEYE DEFLECTABLE VIDEOSCOPE EXHIBITED THE OBJECTIVE LENS ADHESIVE WAS PEELED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20634767 ↗
Other Nasopharyngoscope (Flexible Or Rigid) devices
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- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180Olympus Medical Systems Corp. · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)3 recalls1 death408 reports
- VIVIDEO VNL9-CPHoya Corporation · Nasopharyngoscope (Flexible Or Rigid)389 reports
- PENTAX FNL-10RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)322 reports
- SINGLE USE BIOPSY VALVE MAJ-210Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)1 recall221 reports
- SINGLE USE SUCTION VALVE MAJ-209Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)228 reports
- PENTAX FNL-7RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)227 reports
- PENTAX FNL-10RBSHoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)171 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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