VIVIDEO VNL9-CP (UDI 04961333239795)Recalls & reported problems

Hoya Corporation · VIDEO NASO-PHARYNGO-LARYNGOSCOPE VNL9-CP · Class 2

All models of VIVIDEO (2)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Hoya Vivideo VNL9-CP video scope, used to view the nose, throat, and voice box, has 388 reports in the FDA database, with no injuries and no deaths. The reports often describe breaks, fluid or blood leaks, and a display that is erratic, blank, or unclear. The reports record no clinical signs in patients. Reports fell to 7 in the last 12 months from 22 in the 12 months before. 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: 389
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 389 adverse event reports that list this exact device (DI 04961333239795), received between Jul 20, 2021 and Sep 18, 2026 — classified as 389 malfunctions.

The most frequently reported specific device problem is “Break” (127 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

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Break127
Fluid/Blood Leak74
Erratic or Intermittent Display73
No Display/Image58
Optical Obstruction31
Unintended Movement11
Optical Distortion5
Backflow2

Patient problems

No Clinical Signs, Symptoms or Conditions389
Insufficient Information1

Recent adverse event reports

The 25 most recent of 389 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 18, 2026Erratic or Intermittent Display
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 50813596 ↗
MalfunctionAug 3, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50111530 ↗
MalfunctionApr 23, 2026Erratic or Intermittent Display
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 24961747 ↗
MalfunctionApr 8, 2026Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24812446 ↗
MalfunctionMar 4, 2026No Display/Image
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 24504097 ↗
MalfunctionMar 2, 2026Optical Obstruction
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (SHADOW IN IMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24480300 ↗
MalfunctionFeb 16, 2026Erratic or Intermittent Display
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 24341822 ↗
MalfunctionNov 14, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23551322 ↗
MalfunctionOct 24, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23376453 ↗
MalfunctionOct 15, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
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 23287423 ↗
MalfunctionSep 16, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23060140 ↗
MalfunctionJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22325355 ↗
MalfunctionJun 19, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22291096 ↗
MalfunctionJun 19, 2025No Display/Image; No Display/Image
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 22288825 ↗
MalfunctionMay 26, 2025No Display/Image; No Display/Image
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 22083004 ↗
MalfunctionMay 15, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
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 22025182 ↗
MalfunctionMay 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21991109 ↗
MalfunctionApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21879339 ↗
MalfunctionApr 4, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21770485 ↗
MalfunctionApr 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21759506 ↗
MalfunctionMar 28, 2025Erratic or Intermittent Display; Erratic or Intermittent Display
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 21716248 ↗
MalfunctionMar 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21694849 ↗
MalfunctionMar 3, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE (FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21501450 ↗
MalfunctionFeb 5, 2025Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21309746 ↗
MalfunctionNov 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
THE TIME OF EVENT IS UNKNOWN. THERE WAS NO REPORT OF PATIENT HARM. VIDEO IMAGE FAILURE(FLUID DAMAGE).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20793630 ↗

Device details

UDI-DI	`04961333239795`
Brand	VIVIDEO
Model	VNL9-CP
Company	Hoya Corporation
Product code	EOB · Nasopharyngoscope (Flexible Or Rigid)
Class	Class 2
FDA submission	K171011
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 19, 2025

Device type (GMDN): Flexible video otorhinolaryngoscope, reusable

An endoscope with a flexible inserted portion intended for the visual examination of some or all of the ear (external, middle and inner), nasal passages, paranasal sinuses, pharynx, and/or larynx. It is inserted into the body through the appropriate natural orifice and can be used for treatment if it has a working channel. Anatomical images are transmitted to the user by a video system with an image sensor chip at the distal end of the endoscope and the images showing on a monitor (not included); it may include an irrigation/suction channel. This is a reusable device.

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All Nasopharyngoscope (Flexible Or Rigid) devices →

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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