VIVIDEORecalls & reported problems across all models
Hoya Corporation · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 391
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of VIVIDEO by Hoya Corporation in the FDA's device registry (GUDID). Together they are named in 391 adverse event reports in the FDA's MAUDE database, received between Jul 20, 2021 and Sep 18, 2026 — classified as 391 malfunctions.
The most frequently reported specific device problem is “Break” (128 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported VIVIDEO problems
Device problems
- Break128
- Fluid/Blood Leak75
- Erratic or Intermittent Display73
- No Display/Image58
- Optical Obstruction31
- Unintended Movement11
- Optical Distortion5
- Backflow2
Patient problems
- No Clinical Signs, Symptoms or Conditions391
- Insufficient Information1
VIVIDEO models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VIVIDEO VNL9-CPNasopharyngoscope (Flexible Or Rigid)389 reports
- VIVIDEO VNL9-CPNasopharyngoscope (Flexible Or Rigid)2 reports
Recent VIVIDEO adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionApr 7, 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 24796563 ↗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 ↗MalfunctionDec 2, 2025Break; Material Separation; Break; Material Separation
ON 11-NOV-2025, PENTAX MEDICAL BECAME AWARE OF AN EVENT INVOLVING A PENTAX MEDICAL VIDEO NASO-PHARYNGO-LARYNGOSCOPE MODEL VNL9-CP, SERIAL NUMBER (B)(6) IN (B)(6) WITHIN THE APAC REGION. AN ENDOSCOPE PURCHASED IN (B)(6) 2025 WAS RETURNED DUE TO A MALFUNCTION OF THE INSERTION FLEXIBLE TUBE. THE USER BELIEVED THE CAUSE TO BE POOR ADHESION OF INTERNAL MATERIALS AND EXPRESSED STRONG DISSATISFACTION WITH PRODUCT QUALITY. THERE WAS NO REPORT OF PATIENT HARM. THIS EVENT OCCURRED BEFORE USE. THIS EVENT MEETS THE REQUIREMENTS FOR FDA REPORTABILITY. HOWEVER, SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT MEDICAL PERSONNEL, USER FACILITY, IMPORTER, MANUFACTURER, OR PRODUCT CAUSED OR CONTRIBUTED TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23692136 ↗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 ↗
Other Hoya Corporation products
All Hoya Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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