PENTAX Medical VNL11-J10 (UDI 04961333248056)Recalls & reported problems
Hoya Corporation · PENTAX Medical Video Naso-Pharyngo-Laryngoscope VNL11-J10 (Electronic IFU) · Class 2
All models of PENTAX Medical (34)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04961333248056), received between Dec 13, 2021 and Feb 7, 2023 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Break” (6 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.
Most reported problems
Device problems
- Break6
- Component Missing1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2023Component Missing; Component Missing
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. BENDING RUBBER ADHESIVE FALLS OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16316123 ↗MalfunctionNov 1, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15705623 ↗MalfunctionMay 27, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14520554 ↗MalfunctionMay 27, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14520547 ↗MalfunctionMay 27, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14520545 ↗MalfunctionMay 18, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432742 ↗MalfunctionMar 3, 2022Break; Break
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(BLACKOUT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13657599 ↗MalfunctionDec 13, 2021Unintended Movement; Unintended Movement
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12982081 ↗
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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