RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE P4 (UDI 04953170059032)Recalls & reported problems
Olympus Medical Systems Corp. · ENF-P4 RHINO-LARYNGOFIBERSCOPE · Class 2
All models of RHINO-LARYNGOFIBERSCOPE (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus ENF-P4 rhino-laryngofiberscope is a flexible nasopharyngoscope used to look at the nose and throat. The 50 reports mostly describe cleaning difficulties and damage from wear and water exposure — peeling coatings, corrosion on lenses and the control section, sticky controls, and parts detaching or breaking — with no patient involvement noted. There were no deaths or injuries and 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
- 51
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 51 adverse event reports that list this exact device (DI 04953170059032), received between Jun 9, 2021 and Sep 16, 2026 — classified as 51 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (18 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
- Failure to Clean Adequately18
- Detachment of Device or Device Component9
- Device Reprocessing Problem7
- Break5
- Peeled/Delaminated5
- Corroded3
- Contamination /Decontamination Problem2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
Recent adverse event reports
The 25 most recent of 51 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 16, 2026Peeled/Delaminated
The customer reported that the Rhino-Laryngo fiberscope had peeled off coating during inspection for use. During the initial evaluation of the device, it was also observed that the coating was peeled. No patient harm was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793154 ↗MalfunctionJul 31, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099907 ↗MalfunctionMay 5, 2026Break; Corroded; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THAT THE COATING OF THE CONNECTING TUBE IS PEELED (OFF) AND THE CONTROL SECTION HAS CORROSION DUE TO WATER LEAKAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089838 ↗MalfunctionMay 5, 2026Contamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOVIDEOSCOPE LENS HAD CORROSION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25089463 ↗MalfunctionApr 30, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED CORROSION ON THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25042891 ↗MalfunctionApr 23, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED A DIRTY OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24967226 ↗MalfunctionApr 16, 2026Break; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED FOUND THAT THE INSERTION TUBE SURFACE WAS PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24903934 ↗MalfunctionApr 8, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED STICKINESS ON THE CONTROL SECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820085 ↗MalfunctionApr 7, 2026Degraded; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THAT THE COATING ON THE CONNECTING TUBE IS PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24811757 ↗MalfunctionDec 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THAT THE BENDING SECTION COVER (A-RUBBER) IS MISSING. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23871672 ↗MalfunctionOct 31, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED, THE RHINO-LARYNGO FIBERSCOPE EXHIBITED PAINT COMING OUT OF THE SCOPE. IT WAS PEELING, THE PAINT PARTICLES WHERE STICKING TO THE CUSTOMER'S HAND. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23437815 ↗MalfunctionOct 30, 2025Dent in Material; Dent in Material
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED DENT IN MATERIAL ON INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23427215 ↗MalfunctionOct 29, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE HAD DIRT ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410790 ↗MalfunctionOct 28, 2025Environmental Particulates; Environmental Particulates
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE SCOPE HAD DEBRIS ON THE LIGHT GUIDE MOUNT/PRONG. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23406867 ↗MalfunctionOct 28, 2025Poor Quality Image; Poor Quality Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FIBERSCOPE HAD A BLURRY IMAGE DUE TO A DIRTY OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405238 ↗MalfunctionSep 12, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED A RESIDUE STAIN ON THE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23042523 ↗MalfunctionAug 29, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THE IMAGE GUIDE (IG) LENS WAS DIRTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22922864 ↗MalfunctionJul 9, 2025Material Fragmentation; Material Fragmentation
IT WAS REPORTED THE FIBERSCOPE'S OUTER SHELL ON THE INSERTION PART WAS DETACHED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22459460 ↗MalfunctionJun 27, 2025Loss of or Failure to Bond; Corroded; Loss of or Failure to Bond; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT FLEX SCOPE EXHIBITED DIRT IN THE IMAGE, EYEPIECE LENS AND THE GRIP WAS STICKY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22346213 ↗MalfunctionJun 9, 2025Material Separation; Detachment of Device or Device Component; Material Separation; Detachment of Device or Device Component
IT WAS REPORTED THE RHINO-LARYNGO FIBERSCOPE HINGE JOINT ADHESIVE IS RELEASED DISTALLY. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22168100 ↗MalfunctionFeb 19, 2025Device Reprocessing Problem; Device Reprocessing Problem
OLYMPUS WAS INFORMED THAT DURING AN ONSITE VISIT, THE USER FACILITY STAFF WAS NOT COMPLETING THE LEAK TEST CORRECTLY AND MISSING MAJOR LEAKS. ADDITIONALLY, THEY WERE STACKING SCOPES IN THE REPROCESSING AREA AND NOT PROPERLY HANGING THE SCOPES. NO PATIENT INFECTIONS OR INJURIES REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21413802 ↗MalfunctionJan 28, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
IT WAS REPORTED THAT THE RHINO-LARYNGO FIBER SCOPE HAD BROWN FOREIGN MATERIAL ON THE BENDING RUBBER OF THE DISTAL END. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21252848 ↗MalfunctionOct 29, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE RHINO-LARYNGOFIBERSCOPE EXHIBITED FOREIGN OBJECTS IN THE OBJECTIVE LENS, THE LIGHTING LENS, THE BENDING SECTION COVER, AND THE BENDING SECTION COVER BONDING AREA. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20558138 ↗MalfunctionOct 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE HAD THE RESIN PART OF THE IMAGE GUIDE HOSE FALL OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396250 ↗MalfunctionOct 2, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE FIBERSCOPE EXHIBITED FOREIGN OBJECTS IN THE OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353693 ↗
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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