VISERA TRACHEAL INTUBATION VIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
3 open recalls name at least one VISERA TRACHEAL INTUBATION VIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 78
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 3
We found 2 models of VISERA TRACHEAL INTUBATION VIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 78 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2019 and Aug 17, 2026 — classified as 1 injury, 77 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (53 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 still open.
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
VISERA TRACHEAL INTUBATION VIDEOSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0339-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jul 27, 2023Class IIOpen, Classified
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Z-2501-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
- May 26, 2023Class IIOpen, Classified
Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
Z-2340-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported VISERA TRACHEAL INTUBATION VIDEOSCOPE problems
Device problems
- Peeled/Delaminated53
- Detachment of Device or Device Component8
- Failure to Clean Adequately4
- Scratched Material4
- Degraded3
- Loose or Intermittent Connection3
- Material Split, Cut or Torn2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions77
- No Known Impact Or Consequence To Patient1
VISERA TRACHEAL INTUBATION VIDEOSCOPE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE VBRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls77 reports
- VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE VBRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall1 report
Recent VISERA TRACHEAL INTUBATION VIDEOSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 17, 2026Degraded; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50279667 ↗MalfunctionJul 29, 2026Image Display Error/Artifact
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50076313 ↗MalfunctionMay 1, 2026Detachment of Device or Device Component
THE VISERA TRACHEAL INTUBATION VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE GLUE ON THE LIGHT GUIDE LENS WAS CHIPPED WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25061930 ↗MalfunctionApr 29, 2026Degraded
THE TRACHEAL INTUBATION VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED LEAK TEST. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, CHIPPING OFF AT DISTAL END SIDE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25031357 ↗MalfunctionApr 17, 2026Contamination; Obstruction of Flow
THE TRACHEAL INTUBATION VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF AN OBSTRUCTED ORIFICE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, FOREIGN MATERIAL STUCK IN THE BIOPSY PORT CAUSING OBSTRUCTED BRUSH PASSAGE WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24918933 ↗MalfunctionApr 1, 2026Material Fragmentation
THE VISERA TRACHEAL INTUBATION VIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF "IT HAS A HOLE IN IT, THEY NOTICED IT WHILE CLEANING. DOWN TOWARDS THE END OF THE TRIP". THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, THE OBJECTIVE LENS AND THE LIGHT GUIDE WAS FOUND CHIPPED. THERE WAS NO PATIENT INVOLVEMENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24754310 ↗MalfunctionMar 25, 2026Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE VISERA TRACHEAL INTUBATION VIDEOSCOPE HAD THE LIGHT GUIDE LENS PARTIALLY MISSING GLUE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24695169 ↗MalfunctionJan 9, 2026Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE TRACHEAL INTUBATION VIDEOSCOPE HAD A DETACHED DISTAL END. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020185 ↗MalfunctionJan 2, 2026Corroded
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE VISERA TRACHEAL INTUBATION VIDEOSCOPE HAD CORROSION UNDER BENDING SECTION COVER AT LEAK HOLE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23950339 ↗InjuryNov 4, 2025Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn; Material Separation; Detachment of Device or Device Component; Material Split, Cut or Torn
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23471850 ↗MalfunctionSep 18, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TRACHEAL INTUBATION VIDEOSCOPE HAD DIRT ON THE OBJECTIVE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23084762 ↗MalfunctionAug 22, 2025Component Missing; Component Missing
IT WAS REPORTED THE VIDEOSCOPE WAS MISSING A RING ON THE BIOPSY CHANNEL AND THEY WERE UNABLE TO ATTACH THE DISPOSABLE BIOPSY PORT. THE ISSUE WAS IDENTIFIED DURING SETUP/INSPECTION PRIOR TO CLINICAL USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22877232 ↗MalfunctionJul 10, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THE INTUBATION VIDEOSCOPE'S TIP COVER CAME OFF. THE EVENT OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22476070 ↗MalfunctionDec 29, 2024Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THE TRACHEAL INTUBATION VIDEOSCOPE HAD BLACK DEBRIS IN THE ENDOTRACHEAL TUBE. THE ISSUE OCCURRED DURING A THERAPEUTIC PRE-SURGICAL BRONCHOSCOPY BY ANESTHESIOLOGIST, WHILE THE DEVICE WAS INSIDE THE PATIENT. THERE WAS A PROCEDURAL DELAY OF LESS THAN 30 MINUTES UNDER SEDATION. THE PROCEDURE WAS COMPLETED USING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032438 ↗MalfunctionDec 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20879086 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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