TRACHEAL INTUBATION FIBERSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 7 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
5 open recalls name at least one TRACHEAL INTUBATION FIBERSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 616
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 5
We found 7 models of TRACHEAL INTUBATION FIBERSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 616 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2018 and Aug 31, 2026 — classified as 3 injuries, 613 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (495 reports).
5 FDA recall records name at least one of these models by its device identifier, 5 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
TRACHEAL INTUBATION FIBERSCOPE 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 28, 2023Class IIOpen, Classified
Fiberscopes do not have adequate data to support that the suction flow rate meets the device specification.
Z-0557-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗
- 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-0338-2024 · Root cause: Under Investigation by firm · names 2 of these models · 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-2504-2023 · Root cause: Labeling Change Control · names 5 of these models · 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 · names 2 of these models · 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-2341-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗
Most reported TRACHEAL INTUBATION FIBERSCOPE problems
Device problems
- Peeled/Delaminated495
- Microbial Contamination of Device30
- Failure to Clean Adequately25
- Degraded17
- Detachment of Device or Device Component16
- Device Reprocessing Problem14
- Break12
- Material Split, Cut or Torn7
Patient problems
- No Clinical Signs, Symptoms or Conditions607
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient3
- Foreign Body In Patient2
- Device Embedded In Tissue or Plaque1
TRACHEAL INTUBATION FIBERSCOPE models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-DPBRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall332 reports
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-TPBRONCHOSCOPE (FLEXIBLE OR RIGID)1 recall141 reports
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GPBRONCHOSCOPE (FLEXIBLE OR RIGID)3 recalls23 reports
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GPBRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls70 reports
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-DPBRONCHOSCOPE (FLEXIBLE OR RIGID)2 recalls46 reports
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-PBronchoscope (Flexible Or Rigid)2 recalls3 reports
- TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-PBronchoscope (Flexible Or Rigid)1 recall1 report
Recent TRACHEAL INTUBATION FIBERSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Device Reprocessing Problem; Corroded
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50523487 ↗MalfunctionAug 25, 2026Degraded; Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50436665 ↗MalfunctionAug 17, 2026Material Fragmentation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50279549 ↗MalfunctionJul 31, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50105698 ↗MalfunctionJul 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087577 ↗MalfunctionApr 28, 2026Corroded
THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF FAILED LEAK TEST AT DISTAL TIP. 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, CORROSION INSIDE LENS AND FIBER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25018573 ↗MalfunctionApr 15, 2026Detachment of Device or Device Component
THE CUSTOMER DID NOT REPORT A MALFUNCTION. DURING INSPECTION OF THE FIBERSCOPE, GLUE WAS MISSING FROM THE OBJECTIVE AND LIGHT GUIDE LENS WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24885793 ↗MalfunctionApr 6, 2026Detachment of Device or Device Component
THE TRACHEAL INTUBATION FIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF HOLE ON THE DISTAL END. 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, A-RUBBER ADHESIVE WAS DETACHED AT THE DISTAL END WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24789651 ↗MalfunctionMar 25, 2026Material Fragmentation
IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE FIBERSCOPE EXHIBITED A CHIPPED ADHESIVE ON THE OBJECTIVE LENS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688026 ↗MalfunctionMar 17, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TRACHEAL INTUBATION FIBERSCOPE EXHIBITED A CHIPPED LIGHT GUIDE LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24615107 ↗MalfunctionMar 3, 2026Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TRACHEAL INTUBATION FIBERSCOPE EXHIBITED DIRT ON THE IMAGE CONDUCTOR BUNDLE COVER LENS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24495902 ↗MalfunctionMar 2, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TRACHEAL INTUBATION FIBERSCOPE EXHIBITED DISTAL END DETACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24484298 ↗MalfunctionFeb 27, 2026Microbial Contamination of Device
NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24471549 ↗MalfunctionFeb 23, 2026Microbial Contamination of Device
IT WAS REPORTED THAT THE TRACHEAL INTUBATION FIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE ISSUE WAS FOUND DURING A ROUTINE CULTURE OF THE SCOPE. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24422902 ↗MalfunctionFeb 11, 2026Complete Blockage; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TRACHEAL INTUBATION FIBERSCOPE FORCEPS PASSAGE CHANNEL CLOGGED WITH FOREIGN MATERIAL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24311023 ↗
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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