RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V3 (REF N6006640)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 a thin scope used to view the nose and throat. Its 143 reports often describe parts coming loose, such as missing or cracked adhesive on the lens and sheath, and some describe scopes that could not be cleaned properly. There are no deaths and no injuries. No recalls name this device. Reports rose to 44 in the last 12 months from 14 before.
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
- 150
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 150 adverse event reports that list this exact device (DI 04953170411366), received between Sep 16, 2020 and Sep 21, 2026 — classified as 150 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (48 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 Component48
- Device Reprocessing Problem21
- Failure to Clean Adequately21
- Peeled/Delaminated14
- Material Fragmentation11
- Material Split, Cut or Torn9
- Break6
- Corroded4
Patient problems
- No Clinical Signs, Symptoms or Conditions148
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 150 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848768 ↗MalfunctionSep 17, 2026Material Fragmentation
The customer returned the Videoscope to the service center for a separate issue. During Olympus¿ device analysis it was indicated that the Videoscope distal end was was chipped near the light guide lens. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50805843 ↗MalfunctionSep 15, 2026Peeled/Delaminated; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781826 ↗MalfunctionSep 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724677 ↗MalfunctionSep 1, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547732 ↗MalfunctionSep 1, 2026Material Split, Cut or Torn
The customer returned the Videoscope to the service center for a separate issue. During the device analysis, the Service Repair Technician indicates that a reportable malfunction was found. It was determined that the bending section cover (a-rubber) glue has lifted at the distal end side and the a-rubber glue at the insertion tube side has exposed threads. There was no patient involvement. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50535097 ↗MalfunctionAug 27, 2026Detachment of Device or Device Component
The customer returned the Rhino-Laryngo Videoscope for another issue. During evaluation of the device it was noted that the adhesive around the objective lens was missing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50476699 ↗MalfunctionAug 25, 2026Detachment of Device or Device Component
The customer returned the rhino-laryngo videoscope to the service center for a separate issue. During the device analysis, the evaluation indicates that missing bending section cover adhesive was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50430979 ↗MalfunctionAug 19, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50323710 ↗MalfunctionAug 18, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50304096 ↗MalfunctionAug 17, 2026Break
The customer returned the rhino-laryngo videoscope to the service center for a separate issue. During the device analysis, it was indicated that a chipped adhesive on the bending section cover was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50282464 ↗MalfunctionAug 14, 2026Material Fragmentation; Detachment of Device or Device Component
The customer returned the Rhino Laryngo Videoscope to the service center for a separate issue. During the initial device analysis, the Olympus Service Repair Technician indicated that the adhesive on the Distal Sheath was cracked off and the Objective Lens glue was missing. It was determined that the Distal Sheath adhesive and the Objective Lens glue needed to be replaced. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253165 ↗MalfunctionAug 14, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50253118 ↗MalfunctionAug 11, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50201923 ↗MalfunctionAug 10, 2026Material Discolored; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50194444 ↗MalfunctionAug 7, 2026Material Fragmentation; Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50172294 ↗MalfunctionAug 7, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50171913 ↗MalfunctionAug 6, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50168360 ↗MalfunctionAug 5, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50145406 ↗MalfunctionAug 5, 2026Crack
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142387 ↗MalfunctionAug 4, 2026Material Fragmentation
The customer returned the Rhino-Laryngo Videoscope to the service center for a separate issue. During the device analysis, the Service Engineer indicated that a chip in the objective lens was found. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130306 ↗MalfunctionAug 4, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50126552 ↗MalfunctionMay 5, 2026Loss of or Failure to Bond; Break
IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGO VIDEOSCOPE EXHIBITED THAT THE A-RUBBER GLUE ON THE DISTAL END GLUE IS MISSING, PEELED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089659 ↗MalfunctionMay 1, 2026Material Fragmentation
THE RHINO-LARYNGO VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED THE LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION, THE DEVICE EXHIBITED A CHIP ON THE ADHESIVE OF THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056103 ↗MalfunctionApr 30, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO LARYNGO VIDEOSCOPE HAD A CHIPPED CEMENT AT THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25044579 ↗
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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