BRONCHOFIBERSCOPE BF-PE2 (UDI 04953170062988)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170062988), received between May 3, 2023 and Apr 11, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier, 1 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 16, 2026.

Recalls naming this device

1. Jul 27, 2023Open, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2026Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24851563 ↗
• MalfunctionDec 30, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THE BRONCHOFIBERSCOPE INSERTION TUBE HAD COLOR LOSS AND PARTIAL DISAPPEARANCE OF THE MARKINGS. THE EVENT OCCURRED DURING SET UP IN ROOM. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23925710 ↗
• MalfunctionJun 20, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOFIBERSCOPE TESTED POSITIVE FOR UNSPECIFIED MICROBIAL CONTAMINATION. THE ISSUE WAS FOUND AT REPROCESSING DURING A ROUTINE CULTURE OF THE SCOPE. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17165998 ↗
• MalfunctionMay 3, 2023Scratched Material; Failure to Clean Adequately; Scratched Material; Failure to Clean Adequately

  A FIELD SERVICE ENGINEER REPORTED ON BEHALF OF THE CUSTOMER, BLACK SPOTS VISIBLE IN THE IMAGE ON BRONCHOFIBERSCOPE. THE CUSTOMER REPORTED, THE ISSUE TO BE FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. THE DEVICE WAS RETURNED, AND OLYMPUS REPAIR CENTER FOUND THE FORCEPS CHANNEL PORT SHAVED. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING THE EVALUATION OF THE RETURNED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16865461 ↗