PENTAX FNL-15RP3Recalls & 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 is a PENTAX naso-pharyngo-laryngo fiberscope, a flexible scope used to look at the nose, throat and voice box. The 48 reports mostly describe the scope's fiber image failing — leaking fluid or blood, or breaking — with no mention of patient harm. No deaths or injuries were reported. 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
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04961333224272), received between Mar 9, 2022 and Jun 11, 2024 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (24 reports).
1 other recall cover devices cleared under the same FDA submission (K921707); 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
- Fluid/Blood Leak24
- Break21
- Obstruction of Flow2
- Device Fell1
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions48
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 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 19507972 ↗MalfunctionJun 5, 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 19465643 ↗MalfunctionMar 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 18976595 ↗MalfunctionMar 11, 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 18872728 ↗MalfunctionMar 5, 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 18834122 ↗MalfunctionDec 18, 2023Fluid/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 18342410 ↗MalfunctionNov 27, 2023Break; 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 18207891 ↗MalfunctionNov 17, 2023Break; 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 18157424 ↗MalfunctionSep 20, 2023Fluid/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 17778421 ↗MalfunctionSep 20, 2023Break; 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 17778406 ↗MalfunctionSep 8, 2023Fluid/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 17708517 ↗MalfunctionAug 31, 2023Break; 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 17659530 ↗MalfunctionAug 6, 2023Fluid/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 17467428 ↗MalfunctionJul 25, 2023Fluid/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 17387008 ↗MalfunctionJul 14, 2023Fluid/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 17323300 ↗MalfunctionJul 11, 2023Break; 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 17296119 ↗MalfunctionJun 27, 2023Break; 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 17207290 ↗MalfunctionMay 19, 2023Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16967084 ↗MalfunctionApr 28, 2023Break; 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 16828943 ↗MalfunctionApr 28, 2023Fluid/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 16828934 ↗MalfunctionApr 28, 2023Fluid/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 16828932 ↗MalfunctionApr 28, 2023Fluid/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 16828928 ↗MalfunctionApr 25, 2023Break; 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 16804564 ↗MalfunctionApr 12, 2023Fluid/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 16721586 ↗MalfunctionFeb 13, 2023Obstruction of Flow; Obstruction of Flow
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. OPERATION/SUCTION CHANNEL CLOGGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16361126 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K921707. One submission often covers many models, so check the product and lot details in each record.
- Z-2074-2016 · Apr 6, 2016 · TerminatedNaso-Pharyngo-Laryngoscope Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissu
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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