EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F (UDI 04953170341823)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04953170341823), received between Aug 12, 2020 and May 12, 2026 — classified as 18 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Detachment of Device or Device Component

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED A DETACHED ACOUSTIC LENS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25149834 ↗
• MalfunctionMay 8, 2026Material Fragmentation

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED A CHIP IN THE ADHESIVE AREA BETWEEN THE ACOUSTIC LENS AND THE ULTRASOUND PROBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128246 ↗
• MalfunctionApr 9, 2026Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHO FIBER VIDEOSCOPE DISTAL END HAD A CHIP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830644 ↗
• MalfunctionApr 4, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED THE EL-CONNECTOR HAD CORROSION DUE TO WATER LEAKAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24784364 ↗
• MalfunctionMar 20, 2026Material Separation

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED A CHIP IN THE ADHESIVE AREA BETWEEN THE ACOUSTIC LENS AND THE ULTRASOUND PROBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24650982 ↗
• MalfunctionJan 22, 2026Contamination

  THE CUSTOMER ELABORATED THAT THE SOURCE OF THE FOREIGN MATERIAL WAS THOUGHT TO BE FROM DETERIORATION OBSERVED IN THE SCOPE TUBE AND PEELING OBSERVED INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24156072 ↗
• MalfunctionAug 4, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE HAD NO IMAGE, A BLACK SCREEN. THE EVENT OCCURRED DURING PREPARATION FOR USE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17460547 ↗
• MalfunctionMar 16, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THE LIGHT SOURCE WAS NOT WORKING AND THERE WAS NO LIGHT FROM THE LIGHT GUIDE LENS OF THE DEVICE. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THERE WAS NO IMAGE FROM THE DEVICE. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (NO IMAGE). THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16560469 ↗
• MalfunctionFeb 13, 2023Device Reprocessing Problem; Component Missing; Device Reprocessing Problem; Component Missing

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE HAD THE BENDING RUBBER BECOME DAMAGED DURING REPROCESSING. IT WAS DAMAGED DUE TO THE CAP NOT BEING CORRECTLY PLACED ON THE SCOPE DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16364227 ↗
• MalfunctionJan 17, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED THE EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE HAD NO IMAGE DURING PREPARATION FOR USE IN A DIAGNOSTIC PROCEDURE. THE CUSTOMER TRIED CHANGING THE SETTINGS TO SEE IF THE PICTURE WOULD COME UP, BUT THE ISSUE WAS NOT RESOLVED. ANOTHER SCOPE WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS DELAYED 10-15 MINUTES TO SET UP THE NEW SCOPE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16182313 ↗
• MalfunctionApr 15, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTED THE METAL PART AT THE BIOPSY PORT ON THE SCOPE HAD COME OFF. ADDITIONAL DETAILS WERE REQUESTED REGARDING THE REPORTED EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14118642 ↗
• MalfunctionMay 12, 2021Break; Break

  AS REPORTED FOR THIS EVENT, DURING AN UNKNOWN PROCEDURE, THE ULTRASOUND TIP OF THE DEVICE WAS OBSERVED TO HAVE THE LITTLE BOLD PIECE MISSING. THERE IS NO REPORTED HARM OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11812213 ↗
• MalfunctionJan 29, 2021Break; Break

  A USER FACILITY REPORTED DURING THE MIDDLE OF A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND PROCEDURE, THE TIP OF THE SCOPE AND BALLOON FELL INTO THE PATIENT'S LUNG. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PROCEDURE WAS COMPLETED WITH EBUS SCOPE SN# (B)(4). THE LOT NUMBER OF THE BALLOON THAT FELL INTO THE PATIENT WAS O8K-MAJ-1351. THE TIP AND BALLOON WERE RETRIEVED USING SUCTION THROUGH A THERAPEUTIC BRONCHOSCOPE. NO IMAGING OR ADDITIONAL SURGERY WAS REQUIRED TO RETRIEVE THE BALLOON AND TIP. AT THE TIME OF THE EVENT, THE DOCTOR WAS OBTAINING SPECIMENS. NO PATIENT DEMOGRAPHICS WERE PROVIDED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11254956 ↗
• MalfunctionNov 22, 2020Material Fragmentation; Leak/Splash; Material Fragmentation; Leak/Splash

  THE SERVICE CENTER WAS INFORMED THAT DURING A PROCEDURE, FOREIGN MATERIAL WAS FALLING FROM THE SCOPE¿S CHANNEL. IT IS UNKNOWN IF THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10881552 ↗
• MalfunctionNov 6, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE SERVICE CENTER WAS INFORMED BY THE USER FACILITY THAT DURING REPROCESSING, THE EVIS EXERA II ULTRASONIC BRONCHO-FIBER VIDEOSCOPE WAS FOUND LEAKING AT THE BENDING TIP. NO PATIENT INJURY OR HARM WAS REPORTED TO OLYMPUS.

  Patient problems: No Patient Involvement

  MAUDE report 10801163 ↗
• MalfunctionNov 2, 2020Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT DURING PREPARATION FOR USE, THE DEVICE TIP WAS FOUND MISSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORT. NO USER INJURY REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10774531 ↗
• MalfunctionOct 19, 2020Break; Material Discolored; Scratched Material; Break; Material Discolored; Scratched Material

  AS REPORTED FOR THIS EVENT, DURING REPROCESSING THE DISTAL END OF THE DEVICE WHICH HOLDS THE BALLOON HAD BROKEN OFF. THE PROCEDURE THAT HAD BEEN PERFORMED WAS THERAPEUTIC AND COMPLETED WITH NO DELAY AND WITH THE SAME DEVICE. THERE WAS NO HARM OR ADVERSE IMPACT TO THE PATIENT. THERE WERE NO OTHER DEVICES ASSOCIATED OR REPLACED IN THE EVENT. THERE WAS NO VISUAL DEFORMATION NOTED ON THE BENDING SECTION OF THE SCOPE. HOW THE DEVICE WAS DAMAGED IS NOT KNOWN. THE DEVICE IS MANUALLY CLEANED AND PUT INTO THE AUTOMATIC REPROCESSOR. THERE WAS NO METAL PROTRUDING AND THE BENDING SECTION WAS NOT BROKEN. THE DEVICE IS BEING LEAK TESTED AFTER EACH USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10702278 ↗
• MalfunctionAug 12, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING THE REPROCESSING AT USER FACILITY, IT WAS FOUND THAT THE DETACHMENT OF THE INSTRUMENT CHANNEL PORT FROM THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10394916 ↗