RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 (UDI 04953170411380)Recalls & reported problems
Olympus Medical Systems Corp. · RHINO-LARYNGO VIDEOSCOPE · Class 2
All models of RHINO-LARYNGO VIDEOSCOPE (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus rhino-laryngo videoscope is used to examine the nose and throat. The 26 reports mostly describe parts coming loose or separating, and problems with cleaning, including residue on the lens; they mention no deaths and no 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
- 28
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04953170411380), received between Jul 10, 2023 and Sep 17, 2026 — classified as 28 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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
- Detachment of Device or Device Component6
- Device Reprocessing Problem5
- Failure to Clean Adequately5
- Crack3
- Contamination2
- Corroded2
- Material Separation2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Device Reprocessing Problem; Leak/Splash
It was reported the videoscope failed a sterilization processing load three times during an unspecified event. Fluid was present after aeration. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805606 ↗MalfunctionSep 8, 2026Material Split, Cut or Torn
The customer returned the videoscope to the service center for evaluation related to a separate issue. During the evaluation, a reportable malfunction was identified: the coating on the insertion tube was found to be peeled. As a result, the affected component required replacement. There was no patient involvement associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50675852 ↗MalfunctionAug 31, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50519461 ↗MalfunctionAug 12, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50228443 ↗MalfunctionAug 12, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50226513 ↗MalfunctionJul 27, 2026Crack; Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50041104 ↗MalfunctionMay 8, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED RESIDUE BUILDUP ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25125109 ↗MalfunctionApr 9, 2026Contamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO LARYNGO VIDEOSCOPE OBJECTIVE LENS HAD RESIDUE BUILDUP ON THE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24830742 ↗MalfunctionMar 30, 2026Contamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE HAD A RUBBER CRYSTALLIZATION FOREIGN MATERIAL ON THE BENDING SECTION COVER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24728008 ↗MalfunctionMar 30, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED OBJECTIVE LENS HAD CHIPPED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24720274 ↗MalfunctionJan 8, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE BENDING SECTION COVER EXHIBITS CRYSTALLIZATION FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004071 ↗MalfunctionJan 5, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE HAD A RESIDUE INSIDE THE OBJECTIVE LENSES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23966648 ↗MalfunctionOct 30, 2025Corroded; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THE LIGHT GUIDE LENS HAD A RUST INSIDE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23431463 ↗MalfunctionOct 30, 2025Material Separation; Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THAT THE A-RUBBER IS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23425332 ↗MalfunctionOct 24, 2025Corroded; Corroded
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE SUBJECT DEVICE HAD CORROSION ON THE LIGHT GUIDE BUNDLE OF THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23386401 ↗MalfunctionAug 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED MISSING GLUE ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22834834 ↗MalfunctionJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SUBJECT DEVICE EXHIBITED THE FLEXIBLE INSERTION PART HAD BROKEN OFF FROM THE BOOT OF THE SUBJECT DEVICE. THE ISSUE OCCURRED DURING REPROCESSING. NO OTHER DEVICES WERE INVOLVED. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22238244 ↗MalfunctionJun 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE VIDEOSCOPE EXHIBITED A DETACHED BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22206311 ↗MalfunctionNov 5, 2024Poor Quality Image; Gas/Air Leak; Poor Quality Image; Gas/Air Leak
THERE IS NO FURTHER REPORTABLE INFORMATION FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20613962 ↗MalfunctionMay 9, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED, THAT THE RHINO-LARYNGO VIDEOSCOPE HAD BLISTERS ON THE BENDING SECTION RUBBER AND INSERTING PART, THAT COULD BE CAUSED BY AN ULTRAVIOLET CLEANING MACHINE AS SUSPECTED BY THE CUSTOMER. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19281201 ↗MalfunctionMay 9, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE RHINO-LARYNGO VIDEOSCOPE HAD FIXATED PROTEINS ON THE BENDING SECTION RUBBER AND INSERTING PART. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19279764 ↗MalfunctionMay 9, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS REPORTED THE RHINO-LARYNGO VIDEOSCOPE HAD BLISTERS ON THE BENDING SECTION RUBBER AND INSERTING PART THAT COULD BE THE CAUSED BY THIS METHOD OF CLEANING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19279387 ↗MalfunctionApr 26, 2024Degraded; Degraded
IT WAS REPORTED THE RHINO-LARYNGO VIDEOSCOPE HAD BLISTERS ON THE BENDING SECTION AND INSERTION PART. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19192510 ↗MalfunctionMar 24, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE VIDEOSCOPE EXHIBITED FOREIGN MATERIAL IN RUBBER INSERT CURVATURE AND ADHESIVE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18966551 ↗MalfunctionJan 8, 2024Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT THE RHINO-LARYNGO VIDEOSCOPE WAS USED ON A PATIENT WITHOUT REPROCESSING AFTER IT CAME BACK FROM REPAIR. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18465892 ↗
Other Endoscope, accessories, narrow band spectrum devices
- EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall7,688 reports
- HD CAMERA HEAD OLYMPUS CH-S190-08-LBOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum3,793 reports
- EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190LOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum2 recalls2,828 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum6 deaths2,362 reports
- VISERA ELITE VIDEO SYSTEM CENTER OLYMPUS OTV-S190Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,563 reports
- HD AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S190-XZ-EOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1,424 reports
- VIDEO SYSTEM CENTER Type A OLYMPUS CV-170Olympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum841 reports
- EVIS EXERA II DUODENOVIDEOSCOPE TJF-Q180VOlympus Medical Systems Corp. · Endoscope, accessories, narrow band spectrum1 recall3 deaths653 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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