PENTAX FNL-10RP3Recalls & reported problems
Hoya Corporation · NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES · Class 2
All models of PENTAX (72)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Pentax nasopharyngoscope has 322 reports, all malfunctions, with no deaths and no injuries. Many describe broken fibers that spoil the image and fluid or blood leaking inside. No recalls name this device. Reports fell to 3 in the last 12 months from 11 in the 12 months before.
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
- 322
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 322 adverse event reports that list this exact device (DI 04961333224258), received between May 15, 2021 and Dec 12, 2025 — classified as 322 malfunctions.
The most frequently reported specific device problem is “Break” (168 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
- Break168
- Fluid/Blood Leak89
- Optical Obstruction28
- Optical Distortion20
- Contamination6
- Detachment of Device or Device Component2
- Material Split, Cut or Torn2
- Overcorrection2
Patient problems
- No Clinical Signs, Symptoms or Conditions322
Recent adverse event reports
The 25 most recent of 322 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 12, 2025Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23786354 ↗MalfunctionDec 5, 2025Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23724270 ↗MalfunctionDec 5, 2025Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23724269 ↗MalfunctionMay 2, 2025Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21947642 ↗MalfunctionFeb 19, 2025Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407855 ↗MalfunctionFeb 19, 2025Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21407838 ↗MalfunctionFeb 6, 2025Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21318884 ↗MalfunctionFeb 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21309898 ↗MalfunctionJan 28, 2025Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21249502 ↗MalfunctionJan 28, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21249494 ↗MalfunctionDec 2, 2024Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20816161 ↗MalfunctionNov 27, 2024Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20794201 ↗MalfunctionNov 20, 2024Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20731327 ↗MalfunctionNov 20, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20731222 ↗MalfunctionOct 28, 2024Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20542123 ↗MalfunctionJul 26, 2024Break; Break
THE TIME OF EVENT IS NOT, DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19834835 ↗MalfunctionJul 25, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19823878 ↗MalfunctionJul 23, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19803332 ↗MalfunctionJul 22, 2024Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19789992 ↗MalfunctionJul 22, 2024Break; Break
THE TIME OF EVENT IS NOT, DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19789975 ↗MalfunctionJul 12, 2024Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE (BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19727689 ↗MalfunctionJul 10, 2024Break; Break
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19708026 ↗MalfunctionJul 9, 2024Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(BROKEN).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19698729 ↗MalfunctionJul 9, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19698587 ↗MalfunctionJul 3, 2024Optical Obstruction; Optical Obstruction
THE TIME OF EVENT IS NOT DURING PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM. FIBER IMAGE FAILURE(SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19663150 ↗
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
- 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
- PENTAX FNL-10RBSHoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)171 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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