BRONCHOFIBERSCOPE BF-TE2 (UDI 04953170063008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170063008), received between Mar 12, 2019 and Sep 18, 2026 — classified as 1 death, 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Microbial Contamination of Device” (4 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831119 ↗
• MalfunctionMar 9, 2026Material Separation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERSCOPE EXHIBITED A CHIP ON THE ADHESIVE AROUND THE LIGHT GUIDE LENS, AND A SHAVED FORCEPS CHANNEL PORT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24543726 ↗
• MalfunctionNov 14, 2025Corroded; Peeled/Delaminated; Corroded; Peeled/Delaminated

  DURING THE DEVICE EVALUATION, IT WAS FOUND THAT THE CONNECTING TUBE HAD PEELING COATING (1 MM 2 OR MORE) ON THE BRONCHOFIBERSCOPE, AND THE CONTROL UNIT WAS ALSO FOUND WITH CORROSION DUE TO WATER LEAKAGE. NO PATIENTS WERE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23555323 ↗
• MalfunctionJul 26, 2023Material Deformation; Material Deformation

  THE CUSTOMER REPORTED TO OLYMPUS THAT BRONCHOFIBERSCOPE THE IMAGE WAS GETTING BLACK SPOT ON IT. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT. THE DEVICE WAS RETURNED AND EVALUATED, AND IT WAS FOUND THAT THE FORCEPS CHANNEL PORT WAS SHAVED. 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 17400091 ↗
• MalfunctionMar 19, 2019Microbial Contamination of Device; Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT AS A RESULT OF MICROBIOLOGICAL TESTING BY THE USER FACILITY, THE SAMPLE COLLECTED FROM THE SUBJECT DEVICE TESTED POSITIVE FOR STENOTROPHOMONAS AND PSEUDOMONAS. THE DEVICE HAD BEEN REPROCESSED WITH AN OLYMPUS AUTOMATED ENDOSCOPE REPROCESSOR MODEL ETD3 (NOT AVAILABLE IN THE USA). OTHER DETAILED INFORMATION SUCH AS THE NUMBER OF MICROBES WAS NOT PROVIDED. THERE WAS NO REPORT OF INFECTION ASSOCIATED WITH THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8434985 ↗
• InjuryMar 12, 2019Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THREE PATIENTS INFECTED WITH PSEUDOMONAS AERUGINOSA AFTER AN UNSPECIFIED PROCEDURE USING THE SUBJECT DEVICE. ONE OF THREE PATIENTS REPORTEDLY DIED. OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN FURTHER INFORMATION, SUCH AS THE OUTCOMES OF THE PATIENTS, THE DATE OF THE PROCEDURES, THE DATE OF DETERMINATION OF THE INFECTIONS AND THE DATE OF THE DEATH, BUT THEY DID NOT PROVIDE ANY INFORMATION. AS RESULT OF MICROBIOLOGICAL TESTS BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE DEVICE. HOWEVER, THE TESTS RESULT CLEARED THE FRENCH GUIDELINE. [FIRST TIME; (B)(6) 2018]. NO MICROBE DETECTED. [SECOND TIME; (B)(6) 2018]. BACILLUS GRAM POSITIVE NON SPORE FORMING BACTERIA (2CFU / 100ML). THE DEVICE HAD BEEN REPROCESSED MANUALLY BY THE USER FACILITY. OLYMPUS IS SUBMITTING MDR ACCORDING TO THE NUMBER OF THE PATIENTS WHO WERE INFECTED POTENTIALLY ASSOCIATED WITH THE ENDOSCOPE. THIS IS 3RD OF 3 REPORTS. (IT IS A REPORT OF THE PATIENT WHO INFECTED BUT NOT DIED).

  Patient problems: Unspecified Infection

  MAUDE report 8415164 ↗
• InjuryMar 12, 2019Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THREE PATIENTS WERE INFECTED WITH PSEUDOMONAS AERUGINOSA AFTER AN UNSPECIFIED PROCEDURE USING THE SUBJECT DEVICE. ONE OF THREE PATIENTS REPORTEDLY DIED. OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN FURTHER INFORMATION, SUCH AS THE OUTCOMES OF THE PATIENTS, THE DATE OF THE PROCEDURES, THE DATE OF DETERMINATION OF THE INFECTIONS AND THE DATE OF THE DEATH, BUT THEY DID NOT PROVIDE ANY INFORMATION. AS RESULT OF MICROBIOLOGICAL TESTS BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE DEVICE. HOWEVER, THE TESTS RESULT CLEARED THE (B)(4) GUIDELINE. FIRST TIME: (B)(6) 2018, NO MICROBE DETECTED. SECOND TIME: (B)(6) 2018, BACILLUS GRAM POSITIVE NON SPORE FORMING BACTERIA (2CFU / 100ML). THE DEVICE HAD BEEN REPROCESSED MANUALLY BY THE USER FACILITY. OLYMPUS IS SUBMITTING MDR ACCORDING TO THE NUMBER OF THE PATIENTS WHO WERE INFECTED POTENTIALLY ASSOCIATED WITH THE ENDOSCOPE. THIS IS 2ND OF 3 REPORTS. (IT IS A REPORT OF THE PATIENT WHO WERE INFECTED BUT NOT DEAD).

  Patient problems: Unspecified Infection

  MAUDE report 8415163 ↗
• DeathMar 12, 2019Microbial Contamination of Device

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT THREE PATIENTS INFECTED WITH PSEUDOMONAS AERUGINOSA AFTER AN UNSPECIFIED PROCEDURE USING THE SUBJECT DEVICE. ONE OF THREE PATIENTS REPORTEDLY DIED. OLYMPUS CONTACTED THE USER FACILITY TO OBTAIN FURTHER INFORMATION, SUCH AS THE OUTCOMES OF THE PATIENTS, THE DATE OF THE PROCEDURES, THE DATE OF DETERMINATION OF THE INFECTIONS AND THE DATE OF THE DEATH, BUT THEY DID NOT PROVIDE ANY INFORMATION. AS RESULT OF MICROBIOLOGICAL TESTS BY THE USER FACILITY, FOLLOWING MICROBES WERE DETECTED FROM THE SAMPLE COLLECTED FROM THE DEVICE. HOWEVER, THE TESTS RESULT CLEARED THE FRENCH GUIDELINE. [FIRST TIME; (B)(6) 2018] NO MICROBE DETECTED. [SECOND TIME; (B)(6) 2018] BACILLUS GRAM POSITIVE NON SPORE FORMING BACTERIA (2CFU / 100ML). THE DEVICE HAD BEEN REPROCESSED MANUALLY BY THE USER FACILITY. OLYMPUS IS SUBMITTING MDR ACCORDING TO THE NUMBER OF THE PATIENTS WHO WERE INFECTED POTENTIALLY ASSOCIATED WITH THE ENDOSCOPE. THIS IS 1ST OF 3 REPORTS. (IT IS A REPORT OF THE PATIENT WHO DIED.).

  Patient problems: Death; Unspecified Infection

  MAUDE report 8415154 ↗