OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XP60 (UDI 04953170308154)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04953170308154), received between Sep 10, 2021 and Jul 30, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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-2491-2023 · Root cause: Labeling Change Control · Recall details · 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.

• MalfunctionJul 30, 2026Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086717 ↗
• MalfunctionSep 15, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOFIBERSCOPE EXHIBITED COATING OF THE INSERTION TUBE WAS PEELED OFF. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20221104 ↗
• MalfunctionAug 18, 2022Contamination; Failure to Clean Adequately; Contamination; Failure to Clean Adequately

  CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR OF A BLURRY IMAGE ISSUE NOTED DURING PREPARATION FOR USE. THERE IS NO PATIENT INVOLVEMENT AND NO HARM REPORTED TO ANY PATIENT. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THE DISTAL END WAS DIRTY WITH FOREIGN MATERIAL AROUND THE BIOPSY CHANNEL OPENING. THIS MEDWATCH IS BEING SUBMITTED FOR THE ISSUE OF FOREIGN MATERIAL AROUND THE BIOPSY CHANNEL OPENING AS OBSERVED DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15250657 ↗
• MalfunctionNov 25, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED DURING THE INCOMING INSPECTION FOR REPAIR AT OLYMPUS (B)(4), THAT IT WAS FOUND THE COATING OF THE INSERTION TUBE OF THE SUBJECT DEVICE WAS PEELED OFF MORE THAN 1MM2. THE SUBJECT DEVICE HAD BEEN RETURNED TO OLYMPUS CHINA FOR REPAIR OF THE OF THE INSERTION TUBE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12876335 ↗
• 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 12455801 ↗
• 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 12455757 ↗
• 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 12453495 ↗
• 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 12453461 ↗