OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE N20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170051142), received between Sep 14, 2020 and Jul 1, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

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 18, 2026.

Recalls naming this device

1. Jul 27, 2023Class IIOpen, Classified

   Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.

   Z-2502-2023 · 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.

• MalfunctionJul 1, 2024Mechanical Problem; Mechanical Problem

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOFIBERSCOPE EXHIBITED THE DOWN ANGULATION NOT WORKING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643002 ↗
• MalfunctionAug 15, 2022Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  CUSTOMER REPORTED WITH AN ISSUE OF AIR/WATER LEAKAGES. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. DEVICE EVALUATION FOUND THERE IS A MISSING PART (DISTAL END ) OF THE SCOPE. THIS REPORT IS BEING SUBMITTED FOR MISSING PART OF THE SCOPE (DISTAL END) WHICH WAS NOTED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15229379 ↗
• InjurySep 10, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT IS REPORTED BY THE CUSTOMER, AN UNSPECIFIED TIME AFTER A PROCEDURE USING ONE OF THEIR 10 BRONCHOSCOPES, PRELIMINARY FINDINGS OF FUNGAL CULTURE SPECIMEN COLLECTED FROM THE PATIENT VIA BRONCHOALVEOLAR LAVAGE (BAL) FROM RIGHT MIDDLE LOBE (RML) OF LUNG SHOWS: SCANT GROWTH GRAM POSITIVE BRANCHING RODS SUGGESTIVE OF AEROBIC ACTINOMYCETE (ORIGINALLY REPORTED AS MOLD). IT IS UNKNOWN WHAT TREATMENT THE PATIENT REQUIRED AS A RESULT. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN. THE CUSTOMER STATES THAT IT IS NOT KNOWN WHICH OF THEIR 10 BRONCHOSCOPES WAS USED IN THE CASE, AS THE SURGERY STAFF DID NOT DOCUMENT THIS INFORMATION IN THE PROCEDURE RECORD. FOR THIS REASON, THE CUSTOMER IS REQUESTING ALL 10 BRONCHOSCOPES BE EVALUATED TO DETERMINE IF ANY OF THEM ARE POTENTIALLY A CONTRIBUTING FACTOR TO THE POSITIVE PATIENT CULTURE. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER DETAILS HAVE BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-XP60. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER

  Patient problems: Fungal Infection

  MAUDE report 12455473 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED BY THE CUSTOMER, AN UNSPECIFIED TIME AFTER A PROCEDURE USING ONE OF THEIR 10 BRONCHOSCOPES, PRELIMINARY FINDINGS OF FUNGAL CULTURE SPECIMEN COLLECTED FROM THE PATIENT VIA BRONCHOALVEOLAR LAVAGE (BAL) FROM RIGHT MIDDLE LOBE (RML) OF LUNG SHOWS: SCANT GROWTH GRAM POSITIVE BRANCHING RODS SUGGESTIVE OF AEROBIC ACTINOMYCETE (ORIGINALLY REPORTED AS MOLD). IT IS UNKNOWN WHAT TREATMENT THE PATIENT REQUIRED AS A RESULT. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN. THE CUSTOMER STATES THAT IT IS NOT KNOWN WHICH OF THEIR 10 BRONCHOSCOPES WAS USED IN THE CASE, AS THE SURGERY STAFF DID NOT DOCUMENT THIS INFORMATION IN THE PROCEDURE RECORD. FOR THIS REASON, THE CUSTOMER IS REQUESTING ALL 10 BRONCHOSCOPES BE EVALUATED TO DETERMINE IF ANY OF THEM ARE POTENTIALLY A CONTRIBUTING FACTOR TO THE POSITIVE PATIENT CULTURE. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER DETAILS HAVE BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-XP60. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER

  Patient problems: Fungal Infection

  MAUDE report 12455467 ↗
• InjurySep 10, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT IS REPORTED BY THE CUSTOMER, AN UNSPECIFIED TIME AFTER A PROCEDURE USING ONE OF THEIR 10 BRONCHOSCOPES, PRELIMINARY FINDINGS OF FUNGAL CULTURE SPECIMEN COLLECTED FROM THE PATIENT VIA BRONCHOALVEOLAR LAVAGE (BAL) FROM RIGHT MIDDLE LOBE (RML) OF LUNG SHOWS: SCANT GROWTH GRAM POSITIVE BRANCHING RODS SUGGESTIVE OF AEROBIC ACTINOMYCETE (ORIGINALLY REPORTED AS MOLD). IT IS UNKNOWN WHAT TREATMENT THE PATIENT REQUIRED AS A RESULT. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN. THE CUSTOMER STATES THAT IT IS NOT KNOWN WHICH OF THEIR 10 BRONCHOSCOPES WAS USED IN THE CASE, AS THE SURGERY STAFF DID NOT DOCUMENT THIS INFORMATION IN THE PROCEDURE RECORD. FOR THIS REASON, THE CUSTOMER IS REQUESTING ALL 10 BRONCHOSCOPES BE EVALUATED TO DETERMINE IF ANY OF THEM ARE POTENTIALLY A CONTRIBUTING FACTOR TO THE POSITIVE PATIENT CULTURE. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER DETAILS HAVE BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-XP60. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER

  Patient problems: Fungal Infection

  MAUDE report 12454134 ↗
• InjurySep 10, 2021Contamination

  IT IS REPORTED BY THE CUSTOMER, AN UNSPECIFIED TIME AFTER A PROCEDURE USING ONE OF THEIR 10 BRONCHOSCOPES, PRELIMINARY FINDINGS OF FUNGAL CULTURE SPECIMEN COLLECTED FROM THE PATIENT VIA BRONCHOALVEOLAR LAVAGE (BAL) FROM RIGHT MIDDLE LOBE (RML) OF LUNG SHOWS: SCANT GROWTH GRAM POSITIVE BRANCHING RODS SUGGESTIVE OF AEROBIC ACTINOMYCETE (ORIGINALLY REPORTED AS MOLD). IT IS UNKNOWN WHAT TREATMENT THE PATIENT REQUIRED AS A RESULT. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN. THE CUSTOMER STATES THAT IT IS NOT KNOWN WHICH OF THEIR 10 BRONCHOSCOPES WAS USED IN THE CASE, AS THE SURGERY STAFF DID NOT DOCUMENT THIS INFORMATION IN THE PROCEDURE RECORD. FOR THIS REASON, THE CUSTOMER IS REQUESTING ALL 10 BRONCHOSCOPES BE EVALUATED TO DETERMINE IF ANY OF THEM ARE POTENTIALLY A CONTRIBUTING FACTOR TO THE POSITIVE PATIENT CULTURE. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO FURTHER DETAILS HAVE BEEN PROVIDED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-XP60. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS A BF-3C40. CASE WITH PATIENT IDENTIFIER

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12454092 ↗
• MalfunctionSep 14, 2020Component Missing; Component Missing

  IT WAS REPORTED THE DEVICE WAS RETURNED TO OLYMPUS FOR EVALUATION AS PER THE CUSTOMER IT WAS IDENTIFIED THAT DURING REPROCESSING THE FIBER OPTICS ARE BAD [SIC]. DURING ESTIMATION THE DISTAL SHEATH OF THE BENDING SECTION WAS IDENTIFIED TO BE MISSING.

  Patient problems: No Patient Involvement

  MAUDE report 10531733 ↗