RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE P4 (UDI 04953170411069)Recalls & reported problems
Olympus Medical Systems Corp. · RHINO-LARYNGOFIBERSCOPE · Class 2
All models of RHINO-LARYNGOFIBERSCOPE (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170411069), received between Dec 1, 2020 and Sep 30, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 Component3
- Device Reprocessing Problem2
- Failure to Clean Adequately2
- Peeled/Delaminated2
- Component Missing1
- Corroded1
- Material Deformation1
- Material Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Corroded
The customer reported the Rhino-Laryngo Videoscope had a separate issue. During the initial evaluation of the device, it was observed that the connector lens was corroded. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947115 ↗MalfunctionMay 4, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE CONNECTING TUBE COATING WAS PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25069624 ↗MalfunctionApr 14, 2026Failure to Clean Adequately
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24877337 ↗MalfunctionMar 31, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THE INSERTION PART CONNECTING TUBE COATING PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744451 ↗MalfunctionMar 4, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE WAS MISSING THE RING AROUND LIGHT GUIDE COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24506624 ↗MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED A MISSING C-RING FROM THE LIGHT GUIDE PRONG. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23407920 ↗MalfunctionAug 26, 2025Device Reprocessing Problem; Device Reprocessing Problem
NO ADDITIONAL INFORMATION REPORTED BY CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22892345 ↗MalfunctionJul 30, 2025Component Missing; Detachment of Device or Device Component; Material Deformation; Component Missing; Detachment of Device or Device Component; Material Deformation
IT WAS REPORTED THE SUBJECT DEVICE HAD INSERTION TUBE CRUMPLED, INSERTION TUBE WRINKLED NEAR THE CONE AND FITTING PIN IS MISSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22669020 ↗MalfunctionOct 22, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THE RHINO-LARYNGO FIBERSCOPE HAD BLACK SPOT ON DISTAL END. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20503869 ↗MalfunctionFeb 16, 2021Device Reprocessing Problem; Device Reprocessing Problem
AS REPORTED FOR THIS EVENT, THE CUSTOMER REPORTED THAT A LEAK TEST IS NOT DONE ON THE DEVICE. THERE IS NO REPORTED HARM TO ANY PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11335033 ↗MalfunctionDec 1, 2020Material Separation; Material Separation
IT WAS REPORTED THE DISTAL END OF THE RHINO-LARYNGO FIBERSCOPE SEPARATED DURING REPROCESSING.
Patient problems: No Patient Involvement
MAUDE report 10927942 ↗
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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