OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60 (UDI 04953170308161)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170308161), received between Feb 15, 2024 and Mar 25, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (3 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-0327-2024 · 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-2490-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2026Corroded; Degraded

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE OES BRONCHOFIBERSCOPE FORCEPS CHANNEL PORT HAS CORROSION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24689934 ↗
• MalfunctionNov 6, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE'S PLASTIC DISTAL END COVER WAS BURNED OR MELTED AROUND THE INSTRUMENT CHANNEL OUTLET AT THE DISTAL END. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20623718 ↗
• MalfunctionJun 17, 2024Degraded; Peeled/Delaminated; Degraded; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THE BRONCHOFIBERSCOPE EXHIBITED PEELING OF THE INSERTION TUBE COATING GREATER THAN OR EQUAL TO 1-2 MILLIMETERS AND THE MARKING LINES HAD WORN AND WERE OUT OF SPECIFICATION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547724 ↗
• MalfunctionJun 3, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOFIBERSCOPE EXHIBITED FOREIGN MATERIAL FOUND ON THE CONNECTOR. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19448640 ↗
• MalfunctionApr 18, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED THAT THE COATING ON THE IMAGE GUIDE PIPE WAS PEELING OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140778 ↗
• MalfunctionFeb 27, 2024No Display/Image; Poor Quality Image; Failure to Clean Adequately; No Display/Image; Poor Quality Image; Failure to Clean Adequately

  ADDITIONAL INFORMATION PROVIDED, CONFIRMED THAT NOTHING FELL INTO THE PATIENT'S BODY. THE FIELD ENGINEER SELECTED THIS OPTION BY MISTAKE. THE BLACK SCREEN MALFUNCTION ISSUE REPORTED WAS FOUND DURING PREPARATION FOR USE PRIOR TO AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18793172 ↗
• MalfunctionFeb 15, 2024Peeled/Delaminated; Failure to Clean Adequately; Peeled/Delaminated; Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION THAT THE COATING WAS PEELED FROM THE SOFT TUBE AND THERE WAS FOREIGN MATTER ON THE TIP COVER OF THE BRONCHOFIBERSCOPE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18710692 ↗