TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-DP (UDI 04953170136856)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04953170136856), received between Jan 10, 2019 and Feb 27, 2026 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (41 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.

Recalls naming this device

1. 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 ↗

2. 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionJun 10, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE INTUBATION FIBERSCOPE EXHIBITED COATING OF LIGHT GUIDE HOSE PEELED OFF. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505993 ↗
• MalfunctionMar 15, 2024Peeled/Delaminated; Peeled/Delaminated

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18917208 ↗
• MalfunctionDec 14, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE GASTROINTESTINAL HAD A FIBER WATER LEAKAGE. THERE WERE NO REPORTS OF PATIENT HARM. DURING THE EVALUATION THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: FOREIGN MATTER IN NOZZLE. 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 18332848 ↗
• MalfunctionNov 30, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE TRACHEAL INTUBATION FIBERSCOPE HAD SCRATCH ON THE RUBBER. THERE WERE NO REPORTS OF PATIENT HARM. THE DEVICE WAS RETURNED FOR EVALUATION. DURING THE DEVICE EVALUATION, THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE CONNECTING TUBE HAD COATING PEELING. (1MM2OR MORE). 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 18235517 ↗
• MalfunctionNov 28, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TRACHEAL INTUBATION FIBERSCOPE, INSERTION TUBE WAS CRUSHED. NO REPORTS OF PATIENT HARM. DURING THE EVALUATION THE FOLLOWING REPORTABLE MALFUNCTION WAS FOUND: THE CONNECTING TUBE COATING WAS PEELING (1MM2 OR MORE). 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 18214237 ↗
• MalfunctionSep 27, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TRACHEAL INTUBATION FIBERSCOPE HAD AN AIR/WATER LEAK. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. EXAMINATION SHOWED THE INSERTION SECTION'S COATING WAS PEELING; THE PEELING AREA MEASURED 1 MM2 OR MORE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17829149 ↗
• MalfunctionSep 19, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TRACHEAL INTUBATION FIBERSCOPE HAD PIN HOLES IN THE BENDING SECTION COVER. THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION. DURING EVALUATION, THE CONNECTING TUBE WAS FOUND TO HAVE PEELING COATING: THE PEELING AREA MEASURED 1 MM2 OR MORE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17778075 ↗
• MalfunctionSep 18, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE TRACHEAL INTUBATION FIBERSCOPE HAD BLACK DOTS. THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS RETURNED, EVALUATED, AND THE COAT OF THE IMAGE GUIDE SERPENTINE WAS FOUND PEELED (1MM2). THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17770065 ↗
• MalfunctionAug 31, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE TRACHEAL INTUBATION FIBERSCOPE WAS INSPECTED BEFORE USE AND THE IMAGE BECAME BLACK. THE ISSUE WAS FOUND DURING PROCEDURE, AND THE THERAPEUTIC PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. DURING EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE COAT WAS PEELING OFF AT THE INSERTION SITE AND THEREFORE IS CONSIDERED A MEDICAL DEVICE REPORT (MDR). THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17664783 ↗
• MalfunctionAug 31, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THE TRACHEAL INTUBATION FIBERSCOPE HAD A PINHOLE. 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 17661146 ↗
• MalfunctionAug 14, 2023Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE TIP OF THE TRACHEAL INTUBATION FIBERSCOPE WAS BITTEN. THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS RETURNED, EVALUATED, AND IT WAS FOUND THAT THE COATING OF THE IMAGE GUIDE SERPENTINE WAS PEELING OFF (1MM2 OR MORE). THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541651 ↗
• MalfunctionAug 4, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE TRACHEAL INTUBATION FIBERSCOPE HAD AN ANGULATION MALFUNCTION AND THE IMAGE WAS OUT OF FOCUS/ BLURRY. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT. UPON DEVICE RETURN AND EVALUATION, IT WAS OBSERVED THAT THE COATING ON THE CONNECTING TUBE HAD PEELING WHICH IS A REPORTABLE EVENT. 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 17466004 ↗
• MalfunctionJul 28, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE TRACHEAL INTUBATION FIBERSCOPE HAS FOG ON THE LENS THAT CANNOT BE REMOVED. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT. UPON DEVICE RETURN AND EVALUATION, IT WAS OBSERVED THAT THE COATING ON THE CONNECTING TUBE HAS PEELING WHICH IS A REPORTABLE EVENT. 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 17419006 ↗
• MalfunctionJul 21, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TRACHEAL INTUBATION FIBERSCOPE HAD AN AIR/WATER LEAK. THERE WAS NO REPORT OF PATIENT HARM. THE DEVICE WAS RETURNED, EVALUATED, AND IT WAS FOUND THAT THE COATING OF THE IMAGE GUIDE SERPENTINE WAS PEELING OFF (1MM2 OR MORE). THIS MDR IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17372558 ↗
• MalfunctionJul 18, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TRACHEAL INTUBATION FIBERSCOPE HAD LEAKAGE FROM NEAR THE OPERATION PART. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND THE IMAGE GUIDE CORRUGATED TUBE HAD COATING PEELING. 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 17347203 ↗
• MalfunctionJul 2, 2023Peeled/Delaminated; Peeled/Delaminated

  THE TRACHEAL INTUBATION FIBERSCOPE WAS RETURNED FOR ANNUAL INSPECTION. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. DURING DEVICE EVALUATION AT OLYMPUS, IT WAS FOUND THE CONNECTING TUBE COATING 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 17244499 ↗
• MalfunctionJun 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THE TRACHEAL INTUBATION FIBERSCOPE EXHIBITED SIGNS THAT THE TIP WAS DAMAGED BY GAS STERILIZATION WITHOUT ATTACHING THE CAP. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. DURING TESTING AND INSPECTION OF THE RETURNED DEVICE, THE BENDING SECTION COVER (A-RUBBER) WAS DETACHED. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17182345 ↗
• MalfunctionMay 10, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS, THE TRACHEAL INTUBATION FIBERSCOPE EXHIBITED AIR/WATER LEAKAGE, INSUFFICIENT SUCTION VOLUME. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT. DURING INSPECTION AND TESTING OF THE RETURNED DEVICE, THE CONNECTING TUBE HAD COATING PEELING. (1MM2 OR MORE). THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16904397 ↗
• MalfunctionMay 2, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THE BENDING SECTION COVER ADHESIVE OF THE TRACHEAL INTUBATION FIBERSCOPE HAD A PINHOLE. 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 16853067 ↗
• MalfunctionApr 26, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE TRACHEAL INTUBATION FIBERSCOPE WAS HAVING ANGULATION PROBLEMS. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THE CONNECTING TUBE COATING WAS PEELING. 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 16814232 ↗
• MalfunctionApr 14, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE TRACHEAL INTUBATION FIBERSCOPE HAD AN ABNORMAL APPEARANCE OF THE CONTROL SECTION INCLUDING THE SWITCH. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT. UPON DEVICE RETURN AND EVALUATION, IT WAS OBSERVED THE COATING OF THE CONNECTING TUBE WAS PEELING WHICH, IS A REPORTABLE EVENT. 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 16745849 ↗
• MalfunctionMar 22, 2023Failure to Clean Adequately; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THE TRACHEAL INTUBATION FIBERSCOPE SUCTION CHANNEL IS CLOGGED. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16595165 ↗
• MalfunctionMar 13, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THE TRACHEAL INTUBATION FIBERSCOPE HAD DEFECTS ON THE BENDING SECTION AND ON THE INSERTION TUBE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT. UPON DEVICE RETURN AND EVALUATION, IT WAS OBSERVED THAT THE COATING OF THE CONNECTING TUBE WAS PEELING WHICH, IS A REPORTABLE EVENT. 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 16535162 ↗
• MalfunctionMar 1, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE TRACHEAL INTUBATION FIBERSCOPE HAD AN AIR LEAK, DISCONNECTION. DURING INSPECTION AND EVALUATION, THE COATING OF THE IMAGE GUIDE SERPENTINE IS PEELING OFF (1MM2 OR MORE). 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 16463323 ↗