TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP (UDI 04953170340215)Recalls & reported problems
Olympus Medical Systems Corp. · LF-GP TRACHEAL INTUBATION FIBE RSCOPE-PO · Class 2
All models of TRACHEAL INTUBATION FIBERSCOPE (7)
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 LF-GP tracheal intubation fiberscope is a thin flexible scope used to guide breathing tubes into the airway. Most of the 70 reports describe the scope's outer coating peeling or flaking, parts coming loose, and cleaning or reprocessing problems, with a few mentioning a foreign body left in the patient. There are 3 injuries and no deaths. Two open recalls, started September 2023 and July 2023, concern suction flow not meeting specification and the scope fitting too loosely in the tube connector.
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
- 70
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 2
Summary
The FDA's MAUDE database contains 70 adverse event reports that list this exact device (DI 04953170340215), received between Sep 24, 2019 and Aug 31, 2026 — classified as 3 injuries, 67 malfunctions.
The most frequently reported specific device problem is “Peeled/Delaminated” (26 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 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 · 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 · Recall details · FDA record ↗
Most reported problems
Device problems
- Peeled/Delaminated26
- Detachment of Device or Device Component9
- Failure to Clean Adequately7
- Device Reprocessing Problem6
- Microbial Contamination of Device6
- Degraded4
- Break3
- Material Split, Cut or Torn3
Patient problems
- No Clinical Signs, Symptoms or Conditions65
- Foreign Body In Patient2
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 70 reports, 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 30, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50087577 ↗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 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 ↗MalfunctionFeb 9, 2026Degraded
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE TRACHEAL INTUBATION FIBERSCOPE HAD THE FIBERSCOPE EYEPIECE LENS COATING DETACHED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24293923 ↗MalfunctionJan 8, 2026Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CEMENT WAS MISSING FROM THE OBJECTIVE AND LIGHT GUIDE LENS OF THE FIBERSCOPE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005192 ↗MalfunctionDec 27, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FIBERSCOPE EXHIBITED DUST INSIDE LENS CAUSING A BLURRY IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23902170 ↗MalfunctionDec 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEXIBLE SCOPE ADHESIVE A-RUBBER HAD DETACHED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23802932 ↗MalfunctionAug 28, 2025Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FIBERSCOPE EXHIBITED RESIDUAL LIQUID OR FOREIGN MATERIAL CAME OUT OF CHANNEL-TUBE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22911608 ↗MalfunctionAug 26, 2025Material Separation; Material Separation
DISTAL END DAMAGED/LENS MISSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22894291 ↗MalfunctionJul 31, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE FIBERSCOPE EXHIBITED A TEAR INSIDE THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22673013 ↗MalfunctionJul 21, 2025Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THE SUBJECT DEVICE WAS DAMAGED WITH PHYSICAL FORCE WHILE TRYING TO INTUBATE A PATIENT WITH A SWOLLEN THROAT. THIS OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22553779 ↗MalfunctionJun 18, 2025Failure to Clean Adequately; Failure to Clean Adequately
IT WAS REPORTED THE FIBERSCOPE HAD A FOREIGN OBJECT STUCK AT THE DISTAL TIP DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22288553 ↗MalfunctionMay 12, 2025Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn; Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED THE TRACHEAL INTUBATION FIBERSCOPE WAS UNSHEATHED ON THE DISTAL PART. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT. THE ISSUE WAS FOUND BEFORE PERFORMING THE EXAMINATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22002685 ↗MalfunctionMar 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS OBSERVED DURING THE DEVICE INSPECTION THAT THE FIBERSCOPE EXHIBITED THE BENDING SECTION COVER HAD COME OFF OF THE BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT. THE REPORT CAPTURES THE REPORTABLE MALFUNCTION IDENTIFIED DURING THE OLYMPUS DEVICE EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21725044 ↗MalfunctionMar 17, 2025Degraded; Degraded
NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619983 ↗MalfunctionSep 10, 2024Peeled/Delaminated; Peeled/Delaminated
IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE INTUBATION FIBERSCOPE EXHIBITED THE COATING PEELING 1 TO 2MM OR MORE OFF THE IMAGE GUIDE HOSE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20184619 ↗MalfunctionJul 21, 2024No Display/Image; No Display/Image
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FLEXIBLE SCOPE EXHIBITED THE IMAGE GUIDE SNAKE TUBE DISPLAY IS MISSING (MORE THAN 1MM2). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19787832 ↗
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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