TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP (UDI 04953170061998)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04953170061998), received between Apr 24, 2022 and Sep 18, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (20 reports).

3 FDA recall records name this device's 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, 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.

Recalls naming this device

1. 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 ↗

2. 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 · Recall details · FDA record ↗

3. 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

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING DEVICE EVALUATION, THE FIBERSCOPE CONNECTING TUBE HAD THE COATING PEELING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20245543 ↗
• MalfunctionAug 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FIBERSCOPE EXHIBITED COATING OF THE IMAGE GUIDE HOSE HAD PEELED OFF (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20070673 ↗
• MalfunctionAug 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE FIBERSCOPE EXHIBITED THE COATING PEELED ON THE CONNECTING TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20064738 ↗
• MalfunctionAug 13, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TRACHEAL INTUBATION FIBERSCOPE EXHIBITED FOREIGN SUBSTANCES COMING OUT OF THE TIP DUE TO CLOGGING OF THE BIOPSY CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19978319 ↗
• MalfunctionJul 11, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE FIBERSCOPE¿S COATING OF IMAGE GUIDE HOSE PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726054 ↗
• MalfunctionJun 4, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TRACHEAL INTUBATION FIBERSCOPE EXHIBITED THE COATING ON THE CONNECTING TUBE FOR IMAGE GUIDE WAS PEELING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19462283 ↗
• MalfunctionJun 3, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TRACHAEL INTUBATION FIBERSCOPE EXHIBITED THE COATING OF THE IMAGE GUIDE HOSE PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19454035 ↗
• MalfunctionApr 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE TRACHEAL INTUBATION FIBERSCOPE EXHIBITED PEELED COATING ON THE FLEXIBLE TUBE AT THE INSERTION SITE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197016 ↗
• MalfunctionMar 5, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE FIBERSCOPE EXHIBITED PEELING ON THE CONNECTING TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18838217 ↗
• MalfunctionMar 4, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE INTUBATION FIBERSCOPE EXHIBITED PEELING OFF OF THE COAT OF THE LIGHT GUIDE PIPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18828065 ↗
• MalfunctionFeb 1, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE TRACHEAL INTUBATION FIBERSCOPE EXHIBITED PEELING OF THE IMAGE GUIDE TUBE COATING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628058 ↗
• MalfunctionJan 26, 2024Peeled/Delaminated; Microbial Contamination of Device; Failure to Clean Adequately; Peeled/Delaminated; Microbial Contamination of Device; Failure to Clean Adequately

  IT WAS REPORTED THAT, DURING REPROCESSING, 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 18591965 ↗
• MalfunctionJan 12, 2024Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY RETURNED THE OLYMPUS ASSET, FIBERSCOPE TO THE OLYMPUS SERVICE CENTER. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE COATING OF THE CONNECTING TUBE WAS PEELING. THIS REPORT IS BEING SUBMITTED FOR THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508392 ↗
• MalfunctionJan 10, 2024Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE TRACHEAL INTUBATION FIBERSCOPE HAD A WATER LEAK. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, INSERTION PART SOFT TUBE COATING PEELING OFF WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18489931 ↗
• MalfunctionDec 28, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE FLEXIBLE SCOPE HAD AIR/WATER LEAKAGE. THE ISSUE WAS FOUND DURING AN UNKNOWN EVENT. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE SOFT COATING PEELING OFF WAS FOUND. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18416294 ↗
• MalfunctionNov 30, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE TRACHEAL INTUBATION FIBERSCOPE HAD AN AIR/WATER LEAK. IT WAS UNKNOWN WHEN THE ISSUE WAS FOUND. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: CONNECTING TUBE HAD COATING PEELING (1MM2 OR MORE). THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18237434 ↗
• MalfunctionNov 28, 2023Contamination; Contamination

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING ROUTINE MICROBIOLOGICAL TESTING, THE FIBERSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. 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 18222714 ↗
• MalfunctionAug 3, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TRACHEAL INTUBATION FIBERSCOPE HAD LEAKED FROM THE INSERTION SECTION. THE DEVICE WAS RETURNED AND EVALUATED, AND IT WAS FOUND THAT THE CORRUGATED TUBE COAT WAS PEELING. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THIS MDR (MEDICAL DEVICE REPORT) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17455193 ↗
• MalfunctionJul 12, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE TRACHEAL INTUBATION FIBERSCOPE, HAD A WATER LEAK. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THAT THE THE COATING OF THE IMAGE GUIDE SERPENTINE IS PEELING OFF. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17308075 ↗
• MalfunctionApr 5, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THE INSERTION PART OF THE TRACHEAL INTUBATION FIBERSCOPE WAS LEAKING. THE ISSUE WAS FOUND WHEN PREPARING THE SCOPE FOR USE IN A DIAGNOSTIC PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE COATING OF THE CONNECTING TUBE WAS PEELED. THE REPORT IS BEING SUBMITTED DUE TO THE PEELED COATING FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16680321 ↗
• MalfunctionFeb 28, 2023Material Separation; Material Separation

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TRACHEAL INTUBATION FIBERSCOPE HAD A CRACKED LENS. DURING INSPECTION AND EVALUATION, THE IMAGE GUIDE COIL/SNAKE TUBE COATING PEELING. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING INCOMING INSPECTION AND EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452082 ↗
• MalfunctionAug 3, 2022Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY SUBMITTED A REPAIR REQUEST TO THE OLYMPUS SERVICE CENTER, ON THE TRACHEAL INTUBATION FIBERSCOPE FOR AIR/WATER LEAKAGE. UPON INSPECTION AND TESTING OF THE CUSTOMER RETURNED DEVICE, THE COATING OF THE SCOPE INSERTION GUIDE SERPENTINE TUBE WAS FOUND PEELED OFF. (1-2MM OR MORE). THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, OR USER INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15154564 ↗
• MalfunctionApr 24, 2022Peeled/Delaminated; Peeled/Delaminated

  A USER FACILITY REPORTED THAT THE FIBERSCOPE WIRE IS BROKEN. THE EVENT OCCURRED DURING PREPARATION FOR USE. DURING A STANDARD SERVICE INSPECTION OF THE CUSTOMER RETURNED DEVICE, THE COATING AT THE CONNECTING TUBE WAS PEELED OFF. THIS REPORT IS TO CAPTURE THE REPORTABLE MALFUNCTION FOUND AT INSPECTION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14191355 ↗