RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH (REF N3828333)Recalls & reported problems
Olympus Medical Systems Corp. · 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 a flexible nasopharyngoscope (scope for the nose and throat). The 38 reports mostly describe parts coming apart or falling off — the control section, lighting lens, connecting tube, and image guide tube — plus leaks and cleaning and reprocessing difficulties found during inspection. No reports describe patient harm, and there are no deaths or 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
- 38
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 04953170434693), received between Jun 12, 2023 and Aug 29, 2025 — classified as 38 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 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 Component12
- Failure to Clean Adequately8
- Device Reprocessing Problem7
- Peeled/Delaminated2
- Break1
- Device Dislodged or Dislocated1
- Electrical /Electronic Property Problem1
- Erratic or Intermittent Display1
Patient problems
- No Clinical Signs, Symptoms or Conditions38
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE VIDEOSCOPE'S CONTROL UNIT WAS STICKY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22928015 ↗MalfunctionNov 22, 2024Erratic or Intermittent Display; Erratic or Intermittent Display
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20758469 ↗MalfunctionNov 5, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THE RHINO-LARYNGO VIDEOSCOPE HAD LEAK, WHERE THE LEAK TESTER ATTACHES DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20612017 ↗MalfunctionOct 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE LARYNGO VIDEOSCOPE EXHIBITED THE LIGHTING LENS HAD FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416812 ↗MalfunctionOct 9, 2024Material Integrity Problem; Material Integrity Problem
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RHINO-LARYNGO VIDEOSCOPE'S INSERTION SECTION WAS DAMAGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20408695 ↗MalfunctionSep 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RHINO- LARYNGO VIDEOSCOPE EXHIBITED RESIN PART OF IMAGE GUIDE TUBE FELL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20314787 ↗MalfunctionSep 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEOSCOPE CONNECTING TUBE PART HAD FALLEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20295078 ↗MalfunctionSep 5, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEOSCOPE EXHIBITED FOREIGN OBJECTS IN THE BENDING SECTION COVER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20153014 ↗MalfunctionSep 5, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE VIDEOSCOPE EXHIBITED CONNECTING TUBE TIP COATING FLAKING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20150529 ↗MalfunctionSep 3, 2024Material Separation; Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, EXHIBITED THAT THE RESIN PART OF THE IMAGE GUIDE HOSE HAD FALLEN OFF THE RHINO-LARYNGO VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20125534 ↗MalfunctionAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED PLASTIC PART OF THE CONNECTING TUBE OF THE SUBJECT DEVICE HAD FALLEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20044016 ↗MalfunctionAug 14, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT FOREIGN MATERIAL ADHERED TO THE ANGLE LEVER AND VENTILATION PORT OF THE VIDEOSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19983741 ↗MalfunctionAug 14, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE RESIN ON THE INSERTION TUBE WAS FALLING OFF/PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19983232 ↗MalfunctionJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THE RESIN PART OF THE IMAGE GUIDE HOSE HAS FALLEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19615703 ↗MalfunctionJun 25, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS REPORTED, THE VIDEOSCOPE HAD LOOSENING PARTS ON THE HEAD. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19605893 ↗MalfunctionJun 11, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RHINO-LARYNGO VIDEOSCOPE'S UPWARD AND DOWNWARD ANGULATION LEVER PLATES HAD FOREIGN OBJECTS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510564 ↗MalfunctionJun 4, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THE ILLUMINATION LENS HAS FALLEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19463125 ↗MalfunctionMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE RHINO-LARYNGO VIDEOSCOPE PARTS WERE FALLING OFF THE DISTAL END. THE ISSUE OCCURRED DURING REPROCESSING AND WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19361167 ↗MalfunctionMay 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED A LIGHT GUIDE LENS THAT WAS DISLODGED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19234334 ↗MalfunctionApr 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RHINO LARYNGO VIDEOSCOPE EXHIBITED THE RESIN PART OF THE IMAGE GUIDE HOSE HAD FALLEN OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19155066 ↗MalfunctionApr 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED A TORN SHEATH. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19153284 ↗MalfunctionFeb 21, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED FOREIGN OBJECT IN THE OBJECTIVE LENS AT THE TIP. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18750709 ↗MalfunctionJan 24, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE VIDEOSCOPE HAD FOREIGN MATERIAL AT THE LIGHT GUIDE COVER GLASS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18576222 ↗MalfunctionDec 28, 2023Failure to Clean Adequately; Failure to Clean Adequately
THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGO VIDEOSCOPE HAD A BLURRY IMAGE. THE ISSUE WAS FOUND DURING AN UNKNOWN EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOREIGN MATERIAL IN THE BENDING RUBBER WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18415795 ↗MalfunctionDec 22, 2023Break; Break
THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGO VIDEOSCOPE HAD A WATER LEAK. THE ISSUE WAS FOUND DURING PREPARATION FOR USE OF AN UNKNOWN THERAPEUTIC PROCEDURE. THE PROCEDURE WAS COMPLETED USING A SIMILAR SET OF EQUIPMENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE RESIN PART OF THE IMAGE GUIDE PIPE HAD FALLEN OFF. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18384653 ↗
Other Nasopharyngoscope (Flexible Or Rigid) devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)785 reports
- NA 242268Medos International Sàrl · Nasopharyngoscope (flexible or rigid)573 reports
- 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
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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