OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 (UDI 04953170308123)Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04953170308123), received between Oct 1, 2020 and Apr 21, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Corroded; Residue After Decontamination

  THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF POOR IMAGE QUALITY. 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, EYEPIECE HAD FOREIGN OBJECTS AND FORCEPS CHANNEL PORT HAD CORROSION WERE FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24939293 ↗
• MalfunctionMar 31, 2026Detachment of Device or Device Component

  THE BRONCHOFIBERSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF WATER LEAKAGE FROM UNIVERSAL CORD, AND SLIGHT INDENTATIONS AND WRINKLES ON THE INSERTION TUBE. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, AN MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, CHIPS ON THE DISTAL END COVER WAS FOUND. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744665 ↗
• MalfunctionJul 29, 2025Corroded; Material Discolored; Corroded; Material Discolored

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED A CORRODED FOREIGN MATERIAL ON THE INSERTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649031 ↗
• MalfunctionApr 12, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED COATING PEELING ON THE CONNECTION TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19098626 ↗
• MalfunctionMar 20, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED THAT THE INSERTION TUBE COATING HAD PEELING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18940148 ↗
• MalfunctionNov 7, 2023Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE OES BRONCHOFIBERSCOPE INSERTION TUBE SKIN WAS DAMAGED. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR A DIAGNOSTIC BRONCHOSCOPY WHICH WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18088913 ↗
• MalfunctionMay 15, 2023Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED TO OLYMPUS, THAT THE OES BRONCHOFIBERSCOPE HAD TO UNDERGO DEEP CLEANING; DUE TO DELAYED REPROCESSING. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16934916 ↗
• MalfunctionAug 27, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE PREPARATION FOR USE IT WAS FOUND THAT THE EYEPIECE SECTION OF THE SUBJECT DEVICE HAD BEEN ERODED. DURING THE INCOMING INSPECTION FOR REPAIR AT THE SERVICE DEPARTMENT OF OLYMPUS (B)(4), IT WAS FOUND THAT THE COATING OF THE INSERTION TUBE WAS PARTIALLY PEELED OFF. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12377741 ↗
• MalfunctionJun 23, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR AT LOCAL SERVICE DEPARTMENT OF OLYMPUS, IT WAS FOUND THAT THE COATING ON THE CONNECTING TUBE WAS PEELING OFF. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12047316 ↗
• MalfunctionJan 3, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE INCOMING INSPECTION FOR REPAIR THE AT SERVICE DEPARTMENT OF OLYMPUS (B)(4), IT WAS FOUND THE INSTRUMENT CHANNEL PORT OF THE SUBJECT DEVICE HAD BEEN LOOSENED, DEFORMED, SCRATCHED, RATTLED, OR DETACHED. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11105195 ↗
• MalfunctionOct 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN IN-SERVICE IT WAS OBSERVED THAT THE USER FACILITY DID NOT REPROCESS THE BRONCHOSCOPE BASED ON THE RECOMMENDED REPROCESSING PROTOCOL, AS THE USER FACILITY DID NOT HAVE A SUCTION CLEANING ADAPTER OR SUCTION SOURCE IN THEIR DECONTAMINATION ROOM TO REPROCESS THE BRONCHOSCOPE. THERE WAS NO ADVERSE EVENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10616943 ↗