VISERA TRACHEAL INTUBATION VIDEOSCOPE OLYMPUS LF TYPE V (REF N4500330)Recalls & reported problems
Olympus Medical Systems Corp. · LF-V TRACHEAL INTUBATION VIDEO SCOPE · Class 2
All models of VISERA TRACHEAL INTUBATION VIDEOSCOPE (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Olympus Visera tracheal intubation videoscope is a flexible bronchoscope. The 77 reports mostly describe malfunction, often its coating peeling or parts detaching or cracking, with no deaths and 1 injury. Two recalls are open: unvalidated channel drying could leave water that risks contamination, and labeling now excludes it from certain reprocessors. Reports rose to 10 in the last 12 months from 5.
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
- 77
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 77 adverse event reports that list this exact device (DI 04953170340246), received between Jun 17, 2021 and Aug 17, 2026 — classified as 1 injury, 76 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (52 reports).
2 FDA recall records name this device's identifier, 2 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, 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
Recalls naming this device
- 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 ↗
- 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 problems
Device problems
- Peeled/Delaminated52
- 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
Recent adverse event reports
The 25 most recent of 77 reports, 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 ↗MalfunctionOct 18, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TRACHEAL INTUBATION VIDEOSCOPE EXHIBITED THE COATING ON THE CONNECTING TUBE HAS PEELED OFF (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20483548 ↗MalfunctionOct 16, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE VISERA TRACHEAL INTUBATION VIDEOSCOPE EXHIBITED THE COATING OF THE IMAGE GUIDE HOSE HAS PEELED OFF (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20460423 ↗MalfunctionOct 3, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE VIDEOSCOPE COATING ON THE IMAGE GUIDE TUBE HAD PEELED OFF (1 MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20365262 ↗MalfunctionSep 6, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TRACHEAL INTUBATION VIDEOSCOPE COATING ON THE CONNECTING TUBE WAS FOUND PEELED OFF (1 MM2 OR MORE). THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR USER INJURY ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20163348 ↗MalfunctionSep 5, 2024Loose or Intermittent Connection; Loose or Intermittent Connection
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE VIDEOSCOPE FORCEPS PLUG NOZZLE WAS LOOSE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20145997 ↗MalfunctionJun 28, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TRACHEAL INTUBATION VIDEOSCOPE EXHIBITED A PEELED COATING ON THE FLEXIBLE TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19635763 ↗MalfunctionJun 25, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TRACHEAL INTUBATION VIDEOSCOPE EXHIBITED PEELING-OFF OF THE COATING OF THE IMAGE GUIDE HOSE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19603966 ↗MalfunctionJun 11, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TRACHEAL INTUBATION VIDEOSCOPE EXHIBITED THE COAT OF THE IMAGE GUIDE SNAKE PIPE IS PEELED OFF (MORE THAN 1MM2). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19508874 ↗MalfunctionMay 21, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE INTUBATION VIDEOSCOPE HAD EXHIBITED THE INDICATION ON THE CONNECTING TUBE HAD A DISAPPEARED AREA (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19360742 ↗MalfunctionMay 10, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE SUBJECT DEVICE EXHIBITED A PEELED IMAGE GUIDE TUBE COATING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19293250 ↗
Other BRONCHOSCOPE (FLEXIBLE OR RIGID) devices
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls5 deaths1,557 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1 death1,214 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XP190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls1,146 reports
- Ion 380748Intuitive Surgical, Inc. · Bronchoscope (flexible or rigid)1 recall97 deaths1,278 reports
- VISERA ELITE XENON LIGHT SOURCE OLYMPUS CLV-S190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)1,155 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)5 recalls3 deaths621 reports
- EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190Olympus Medical Systems Corp. · Bronchoscope (Flexible Or Rigid)3 recalls333 reports
- BRONCHOVIDEOSCOPE BF-1T150Olympus Medical Systems Corp. · BRONCHOSCOPE (FLEXIBLE OR RIGID)4 recalls212 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 · each recall links to the FDA recall notice
- 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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