RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP (UDI 04953170059018)Recalls & reported problems
Olympus Medical Systems Corp. · ENF-XP RHINOLARYNNGOSCOPE · Class 2
All models of RHINO-LARYNGOFIBERSCOPE (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus rhinolaryngoscope is a flexible scope used to examine the nose and throat. The 26 reports mostly describe parts detaching or breaking, peeling coatings, and damaged or missing lens covers, with no deaths or injuries reported. There is 1 open recall because Olympus updated cleaning instructions, removing reusable brushes while keeping single-use brushes compatible. Reports rose from 3 to 13 in the latest 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
- 29
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04953170059018), received between Jan 15, 2020 and Sep 18, 2026 — classified as 29 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Dec 4, 2023Class IIOpen, Classified
Olympus has updated the instructions for use: Reusable cleaning brushes have been removed from the manual cleaning. Single use brushes remain compatible.
Z-0688-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component7
- Device Reprocessing Problem4
- Break3
- Mechanical Problem3
- Peeled/Delaminated3
- Component Missing2
- Corroded2
- Failure to Clean Adequately2
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Detachment of Device or Device Component
The customer reported there was an unprotected Distal Tip during reprocessing. The issue involved an Olympus Rhino Laryngofiberscope. Additionally, during the initial device analysis, the Olympus Service Repair Technician indicated that the Insertion Section Distal rubber was detached. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50818804 ↗MalfunctionSep 11, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50737639 ↗MalfunctionSep 4, 2026Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50623729 ↗MalfunctionAug 31, 2026Peeled/Delaminated
It was observed that during the device evaluation, the rhino-laryngofiberscope insertion tube coating was peeled off. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525103 ↗MalfunctionApr 29, 2026Device Reprocessing Problem
NO NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25037730 ↗MalfunctionApr 28, 2026Component Missing
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THE LIGHT GUIDE COVER GLASS MISSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25022986 ↗MalfunctionApr 7, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THE CONNECTOR ¿ LIGHT GUIDE COVER GLASS WAS DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800092 ↗MalfunctionMar 24, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED A CHIP ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24673443 ↗MalfunctionFeb 24, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO LARYNGOFIBERSCOPE HAD A MISSING COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428811 ↗MalfunctionJan 2, 2026Device Reprocessing Problem; Degraded
NO NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952201 ↗MalfunctionDec 30, 2025Loss of or Failure to Bond; Loss of or Failure to Bond
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED MISSING ADHESIVE ON THE DISTAL END, THE PLASTIC DISTAL END, THE OBJECTIVE LENS, AND THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926732 ↗MalfunctionDec 18, 2025Corroded; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED CORROSION INSIDE THE LENS OR THE LIGHT GUIDE PRONG. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23839408 ↗MalfunctionDec 8, 2025Component Missing; Component Missing
NO NEW INFORMATION HAS BEEN PROVIDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23742130 ↗MalfunctionNov 19, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LARYNGOFIBERSCOPE EXHIBITED DIRT ON THE IMAGE GUIDE COVER LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23597993 ↗MalfunctionNov 11, 2025Unstable; Unstable
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE'S LIGHT GUIDE COVER GLASS WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23526912 ↗MalfunctionNov 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE SUBJECT DEVICE DISTAL END SHEATH DISCONNECTED FROM THE BENDING ARM. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23524783 ↗MalfunctionOct 24, 2025Unstable; Unstable
IT WAS REPORTED THAT THE RHINO-LARYNGO VIDEOSCOPE DISTAL HEAD CONTROL POSITION WAS LOOSE. THE ISSUE OCCURRED DURING SERVICE OR MAINTENANCE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23380179 ↗MalfunctionOct 16, 2025Break; Detachment of Device or Device Component; Material Twisted/Bent; Unintended Movement; Break; Detachment of Device or Device Component; Material Twisted/Bent; Unintended Movement
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE TIP WAS ROTATED AND DETACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23311506 ↗MalfunctionJan 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE SCOPE OF THE RHINO-LARYNGO FIBERSCOPE FELL APART DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21072562 ↗MalfunctionOct 31, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED FOREIGN MATERIAL ON THE CURVED RUBBER. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20579670 ↗MalfunctionJun 26, 2024Mechanical Problem; Mechanical Problem
IT WAS REPORTED, THE FIBERSCOPE'S ANGULATION BECAME LOCKED- CANNOT DISENGAGE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19619006 ↗MalfunctionDec 6, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO OLYMPUS, THE RHINO-LARYNGO FIBERSCOPE HAS LOCKED TIE ROD. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18280223 ↗MalfunctionJul 28, 2023Peeled/Delaminated; Peeled/Delaminated
THE CUSTOMER REPORTED TO OLYMPUS MEDICAL THAT THE RHINO-LARYNGO FIBERSCOPE FAILED THE LEAK TEST DUE TO THE DISTAL TIP PEELING OFF. NO ADVERSE EFFECTS TO PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17417323 ↗MalfunctionJul 28, 2023Peeled/Delaminated; Peeled/Delaminated
THE CUSTOMER REPORTED TO OLYMPUS MEDICAL THAT THE RHINO-LARYNGO FIBERSCOPE FAILED THE LEAK TEST DUE TO THE DISTAL TIP PEELING OFF. NO ADVERSE EFFECTS TO PATIENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17417281 ↗MalfunctionApr 28, 2023Mechanical Problem; Mechanical Problem
THE CUSTOMER REPORTED TO OLYMPUS THAT THE RHINO-LARYNGO FIBERSCOPE EXPERIENCED AN ANGULATION MALFUNCTION. THE EVENT OCCURRED DURING PREPARATION FOR USE. THE INTENDED PROCEDURE WAS LISTED AS DIAGNOSTIC. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WERE NO REPORTS OF HEALTH HAZARD TO THE PATIENT OR USER OF THE DEVICE. THE SUBJECT DEVICE WAS SUBSEQUENTLY EVALUATED AND CONFIRMED BY OLYMPUS, AND DETECTED THE ANGLE MIGHT BE LOCKED DUE TO CUT ANGULATION WIRE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16832811 ↗
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 · each recall links to the FDA recall notice
- 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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