RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE GP (UDI 04953170078231)Recalls & reported problems
Olympus Medical Systems Corp. · ENF-GP PORTABLE RHINO-LARYNGO FIBERSCOPE · Class 2
All models of RHINO-LARYNGOFIBERSCOPE (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus Rhino-Laryngofiberscope is a portable flexible scope used to look at the nose, throat, and voice box. The 76 reports mostly describe the distal tip coming loose or falling apart, along with parts breaking, peeling, and problems with cleaning and reprocessing, generally noticed after the procedure with no patient involvement. There are no deaths and no injuries, and no recalls name this device. Reports rose from 10 in the prior 12 months to 42 in the last 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
- 77
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 04953170078231), received between Dec 18, 2020 and Sep 24, 2026 — classified as 77 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (22 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 Component22
- Device Reprocessing Problem11
- Break10
- Peeled/Delaminated9
- Failure to Clean Adequately8
- Loss of or Failure to Bond6
- Material Separation4
- Corroded3
Patient problems
- No Clinical Signs, Symptoms or Conditions76
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 77 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Device Reprocessing Problem
The customer reported the Rhino-Laryngo fiberscope had a separate issue. During the initial evaluation of the device it was observed, that the eyepiece had dirt on it. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885230 ↗MalfunctionSep 21, 2026Failure to Clean Adequately
It was observed that during the device inspection, the Rhino-Laryngofiberscope exhibited the LG-cover glass had foreign objects. There were no reports of patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50835130 ↗MalfunctionAug 14, 2026Detachment of Device or Device Component
The customer reported the tip of the Olympus Rhino-Laryngofiberscope had come apart. The issue was identified during reprocessing. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251317 ↗MalfunctionAug 13, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50234514 ↗MalfunctionAug 11, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50201932 ↗MalfunctionAug 6, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50158736 ↗MalfunctionAug 4, 2026Device Reprocessing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50130006 ↗MalfunctionAug 4, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129857 ↗MalfunctionJul 31, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50096729 ↗MalfunctionJul 30, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50089877 ↗MalfunctionMay 11, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED PEELED OFF COATING ON THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25134961 ↗MalfunctionMay 8, 2026Gas/Air Leak
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE LIGHT GUIDE LENS OF THE LARYNGOFIBERSCOPE DEVICE WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25131310 ↗MalfunctionMay 4, 2026Corroded
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED CORROSION ON THE VENTING CONNECTOR. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25066962 ↗MalfunctionMay 1, 2026Loose or Intermittent Connection
THE RHINO LARYNGOFIBERSCOPE WAS RETURNED TO THE OLYMPUS SERVICE CENTER WITH A REPORT OF LEAKING AT THE LIGHT SOURCE. THIS DOES NOT INDICATE A MEDICAL DEVICE REGULATIONS REPORTABLE EVENT. HOWEVER, A REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE OLYMPUS SERVICE CENTER. DURING INSPECTION OF THE DEVICE, LOOSENESS OF THE LIGHT GUIDE COVER GLASS WAS FOUND DUE TO A CAUSE LINKED TO THE DEVICE BUT UNABLE TO TRACE MORE SPECIFICALLY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057184 ↗MalfunctionApr 30, 2026Break
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED LIGHT GUIDE COVER GLASS IS DEFORMED OR THE GLUE IS CHIPPED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25050946 ↗MalfunctionApr 20, 2026Residue After Decontamination
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGO FIBERSCOPE HAD FOREIGN MATERIAL IN THE EYEPIECE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24926154 ↗MalfunctionApr 16, 2026Break; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED FOUND THAT THE INSERTION TUBE DETACHED FROM THE BENDING SECTION COVER (A-RUBBER) GLUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24897494 ↗MalfunctionApr 13, 2026Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THE COATING ON THE CONNECTING TUBE IS PEELING OFF. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866154 ↗MalfunctionApr 13, 2026Device Reprocessing Problem; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE IMAGE GUIDE COVER LENS WAS DIRTY. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865607 ↗MalfunctionApr 9, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THAT THE ADHESIVE ON THE BENDING SECTION COVER (A-RUBBER) IS DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24835730 ↗MalfunctionApr 8, 2026Degraded; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED THAT THE ADHESIVE ON THE BENDING SECTION COVER (A-RUBBER) IS DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24824478 ↗MalfunctionApr 2, 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 24764940 ↗MalfunctionApr 1, 2026Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED STICKINESS ON THE CONTROL UNIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753193 ↗MalfunctionApr 1, 2026Material Fragmentation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED CHIP ON THE DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753077 ↗MalfunctionMar 31, 2026Material Separation
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE RHINO-LARYNGOFIBERSCOPE EXHIBITED A MINOR CHIP ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24745215 ↗
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