RHINO-LARYNGO FIBERSCOPE ENF-GP2 (UDI 04953170411328)Recalls & reported problems
Olympus Medical Systems Corp. · RHINO-LARYNGO FIBERSCOPE · Class 2
All models of RHINO-LARYNGO FIBERSCOPE (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus Rhino-Laryngo Fiberscope ENF-GP2 is a flexible nasopharyngoscope used to look at the nose and throat. The 31 reports mostly describe the scope not cleaning properly, parts detaching, plastic or fiber pieces chipping or breaking off, a chipped objective lens, corrosion, and poor image quality; none involved a patient. There are no deaths and no 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
- 33
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 04953170411328), received between Sep 6, 2022 and Sep 17, 2026 — classified as 33 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (5 reports).
1 other recall cover devices cleared under the same FDA submission (K181240); they may or may not involve this specific model.
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 Adequately5
- Detachment of Device or Device Component4
- Material Separation4
- Corroded3
- Device Reprocessing Problem2
- Material Fragmentation2
- Mechanical Problem2
- Poor Quality Image2
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 25 most recent of 33 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 17, 2026Material Separation
The customer reported the Rhino-Laryngofiberscope had a separate issue. During the initial evaluation of the device it was observed, that light guide lenses and objective lens (charged coupled device) are missing adhesive. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50803826 ↗MalfunctionSep 9, 2026Corroded; Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50698455 ↗MalfunctionAug 28, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50506749 ↗MalfunctionAug 28, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50502256 ↗MalfunctionAug 26, 2026Environmental Particulates
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50456633 ↗MalfunctionAug 17, 2026Material Fragmentation
The customer returned the Rhino-Laryngofiberscope for a separate issue. During the initial evaluation of the returned device, a chip on the objective lens was observed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50272568 ↗MalfunctionAug 5, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50143489 ↗MalfunctionMay 6, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE RHINO-LARYNGO FIBERSCOPE EXHIBITED THE UNIT PLASTIC DISTAL END COVER CHIPPED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25096368 ↗MalfunctionApr 15, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO LARYNGO FIBERSCOPE EXHIBITED MISSING OBJECTIVE LENS SEALING GLUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24884718 ↗MalfunctionFeb 9, 2026Material Integrity Problem
IT WAS REPORTED THE RHINO-LARYNGO FIBERSCOPE WAS DROPPED AND FOUND TO HAVE FIBERGLASS INSIDE OF THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293880 ↗MalfunctionJan 21, 2026Component Missing
THE CUSTOMER REPORTED THAT THE END OF THEIR RHINO-LARYNGO FIBERSCOPE DEVICE HAD A PIECE MISSING; THE FIBEROPTICS COULD BE OBSERVED COMING THROUGH WHERE THE SHEATH SHOULD BE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24136088 ↗MalfunctionDec 4, 2025Device Reprocessing Problem; Fluid/Blood Leak; Device Reprocessing Problem; Fluid/Blood Leak
IT WAS REPORTED THE RHINO-LARYNGO FIBERSCOPE HAD GRAY DRAINAGE FROM THE SCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23718178 ↗MalfunctionNov 5, 2025Peeled/Delaminated; Peeled/Delaminated
DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE DISTAL END COVER WAS MISSING GLUE ON THE FIBERSCOPE. NO PATIENTS WERE INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23477168 ↗MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED MISSING GLUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23460463 ↗MalfunctionOct 31, 2025Unintended Movement; Unintended Movement
IT WAS REPORTED THAT THE SHEATH ON THE TIP OF THE FIBERSCOPE. WHICH IS INSERTED INTO THE PATIENT¿S NOSE, WAS LOOSE. THE LOCATION WHERE THE EVENT OCCURRED WAS NOT SPECIFIED BY THE REPORTER. NO PATIENT HARM WAS REPORTED IN CONNECTION WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23439595 ↗MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO FIBERSCOPE EXHIBITED THAT THERE WAS A MISSING PART OF THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23414798 ↗MalfunctionOct 29, 2025Mechanical Problem; Mechanical Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO FIBERSCOPE EXHIBITED THE ANGULATION WAS LOCKED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23413769 ↗MalfunctionOct 29, 2025Material Separation; Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THE LIGHT GUIDE LENS SEPARATED BETWEEN DISTAL END METAL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23410645 ↗MalfunctionOct 28, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO FIBERSCOPE EXHIBITED A DIRTY OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23408267 ↗MalfunctionOct 28, 2025Corroded; Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED CORROSION AROUND THE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23400870 ↗MalfunctionOct 27, 2025Corroded; Corroded
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23398098 ↗MalfunctionOct 23, 2025Material Separation; Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED A MISSING COVER GLASS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23368657 ↗MalfunctionOct 22, 2025Poor Quality Image; Poor Quality Image
DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE IMAGE WAS CLOUDY ON THE FIBERSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23358307 ↗MalfunctionOct 16, 2025Degraded; Degraded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED MISSING ADHESIVE FROM THE LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23315754 ↗MalfunctionSep 18, 2025Material Separation; Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SCOPE EXHIBITED LOOSE LIGHT GUIDE COVER GLASS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23082265 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K181240. One submission often covers many models, so check the product and lot details in each record.
- Z-2292-2020 · May 5, 2020 · TerminatedENF-GP2 Rhino-Laryngo Fiberscope - Product Usage: is indicated for use within the nasal and nasopharyngeal lumen.
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.
How reports and recalls are matched · Editorial policy · Report an error on this page