EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F (UDI 04953170243226)Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04953170243226), received between Mar 20, 2019 and Sep 17, 2026 — classified as 4 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Material Deformation; Failure to Clean Adequately

  The customer returned the Bronchofibervideoscope to the service center for a separate issue. During Olympus¿ device analysis it was indicated that the Bronchofibervideoscope's Forceps channel port had a dent and the Connecting tube was sticky. There were no reports of patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50805826 ↗
• MalfunctionApr 14, 2026Material Split, Cut or Torn

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24873047 ↗
• MalfunctionApr 13, 2026Failure to Clean Adequately

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED A STICKY CONTROL UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24859570 ↗
• MalfunctionNov 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE HAD A DETACHED BENDING SECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23457785 ↗
• MalfunctionJul 29, 2025Crack; Crack

  IT WAS OBSERVED DURING OLYMPUS' DEVICE INSPECTION THAT THE BRONCHOFIBERVIDEOSCOPE EXHIBITED A BROKEN PIECE OF THE PROBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22645574 ↗
• MalfunctionFeb 4, 2025Scratched Material; Scratched Material

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE EXHIBITED DEEP SCRATCHES AT THE BIOPSY CHANNEL OPENING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21308250 ↗
• MalfunctionNov 6, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE ULTRASONIC BRONCHOFIBERVIDEOSCOPE DISPLAYED NO IMAGE WHEN USING 180 SERIES SCOPES, THE WHITE BALANCE FAILED TO COMPLETE, AND IT WAS NOTED THAT THE SCREEN DID HAVE THE INFORMATION OVERLAY INCLUDING THE PATIENTS NAME, DATE OF BIRTH, ETC. THE ISSUE WAS FOUND DURING A NAVIGATIONAL BRONCHOSCOPY, ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY, AND ASPIRATION NEEDLE BIOPSY (LASTING 1.25 HOURS), THE PROCEDURES WERE COMPLETED WITH A SIMILAR DEVICE, WITH A FEW MINUTES OF DELAY (THE EXACT TIMEFRAME WAS NOT SPECIFIED). THERE WERE NO REPORTS OF PATIENT HARM AND NO CLINICAL IMPACT. THIS REPORT IS RELATED TO THE FOLLOWING LINKED PATIENT IDENTIFIERS: (B)(6), (B)(6), (B)(6), (B)(6), AND (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18079625 ↗
• MalfunctionApr 9, 2021Break; Break

  AS REPORTED FOR THIS EVENT, THE TIP OF THE ULTRASOUND PROBE WAS FOUND TO BE MISSING AT THE TIME OF PREPARATION FOR AN UNKNOWN EVENT. THERE WAS NO PATIENT INVOLVEMENT. THE DEVICE WAS NOT INSPECTED BEFORE THE START OF SET UP. IT IS NOT KNOWN HOW THE TIP OF THE ULTRASOUND CAME TO BE MISSING. THERE WERE NO ERROR MESSAGES, ALARMS, OR ALERT TONES ASSOCIATED WITH THIS EVENT. THE DEVICE WAS NOT DROPPED, NOR DID THE DEVICE COME IN CONTACT WITH A HARD SURFACE OR SHARP CORNER. THE DEVICE IS STORED HANGING IN A SCOPE CABINET AND IS CLEANED AFTER EVERY USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11644100 ↗
• InjuryApr 9, 2021Device Reprocessing Problem; Device Reprocessing Problem

  THE INDICATION FOR THE BRONCHOSCOPY WAS ABNORMAL COMPUTERIZED TOMOGRAPHY (CT) SCAN WITH BILATERAL LOWER LOBE ATELECTASIS. RESPIRATORY CULTURE RESULTS: LIGHT GROWTH STREPTOCOCCUS, ALPHA HEMOLYTIC FUNGAL: EXOPHIALA SALMONIS / EXOPHIALA CANCERAE. COURSE OF ILLNESS (PHYSICIAN VISITS): PULMONOLOGIST: (B)(6) 2021- HOSPITAL/SCOPE F/U. STILL COMPLAINING OF SHORTNESS OF BREATH (SOB), COUGH, WHEEZING. PULMONOLOGIST: (B)(6) 2021- UNIVERSITY OF ROCHESTER-CONSULT - MEDICATION CHANGES. PULMONOLOGIST: (B)(6) 2021-STILL COMPLAINING OF SOB, WHEEZING IMPROVING. PULMONOLOGIST: (B)(6) 2021- 2 WEEK FOLLOW-UP (F/U), WHEEZING/SOB SIGNIFICANTLY IMPROVED. PULMONOLOGIST: (B)(6) 2021-F/U CONTINUES TO IMPROVE. PULMONOLOGIST: (B)(6) 2021 ROCHESTER PULMONOLOGIST CONSULT- DISCUSSED IMPROVEMENTS. PRIMARY CARE PHYSICIAN (PCP): (B)(6) 2021- INCREASED SOB/WHEEZING, RECOMMENDED TO GO TO EMERGENCY ROOM (ER), PATIENT REFUSED PULM: 3/24/21: HAS HAD WORSENING ASTHMA. PREDNISONE 50 MG STARTED. PULMONOLOGIST: 3/31/21- CONTINUES WITH UNCONTROLLED ASTHMA. CONTINUES WITH COUGH, WHEEZING, SPUTUM. PULMONOLOGIST: 4/22/21: PEAK FLOW NOW AT BASELINE. FEELS HER SYMPTOMS ARE NOW WELL CONTROLLED AT THIS TIME. THE PATIENT RECEIVED ROU

  Patient problems: Respiratory Tract Infection

  MAUDE report 11642050 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem

  THE INDICATION FOR THE BRONCHOSCOPY WAS ABNORMAL COMPUTERIZED TOMOGRAPHY (CT) SCAN WITH BILATERAL LOWER LOBE ATELECTASIS. RESPIRATORY CULTURE RESULTS: LIGHT GROWTH STREPTOCOCCUS, ALPHA HEMOLYTIC FUNGAL: EXOPHIALA SALMONIS / EXOPHIALA CANCERAE. COURSE OF ILLNESS (PHYSICIAN VISITS): PULMONOLOGIST: (B)(6) 2021- HOSPITAL/SCOPE F/U. STILL COMPLAINING OF SHORTNESS OF BREATH (SOB), COUGH, WHEEZING. PULMONOLOGIST: (B)(6) 2021- (B)(6) -CONSULT - MEDICATION CHANGES. PULMONOLOGIST: (B)(6) 2021-STILL COMPLAINING OF SOB, WHEEZING IMPROVING. PULMONOLOGIST: (B)(6) 2021- 2 WEEK FOLLOW-UP (F/U), WHEEZING/SOB SIGNIFICANTLY IMPROVED. PULMONOLOGIST: (B)(6) 2021-F/U CONTINUES TO IMPROVE. PULMONOLOGIST: (B)(6) 2021 ROCHESTER PULMONOLOGIST CONSULT- DISCUSSED IMPROVEMENTS. PRIMARY CARE PHYSICIAN (PCP): (B)(6) 2021- INCREASED SOB/WHEEZING, RECOMMENDED TO GO TO EMERGENCY ROOM (ER), PATIENT REFUSED. PULMONOLOGIST: (B)(6) 2021: HAS HAD WORSENING ASTHMA. PREDNISONE 50 MG STARTED. PULMONOLOGIST: (B)(6) 2021- CONTINUES WITH UNCONTROLLED ASTHMA. CONTINUES WITH COUGH, WHEEZING, SPUTUM. PULMONOLOGIST: (B)(6) 2021: PEAK FLOW NOW AT BASELINE. FEELS HER SYMPTOMS ARE NOW WELL CONTROLLED AT THIS TIME. THE PATIENT RECEIV

  Patient problems: Fungal Infection

  MAUDE report 11641953 ↗
• MalfunctionNov 3, 2020Material Puncture/Hole; Material Puncture/Hole

  THE SERVICE CENTER WAS INFORMED THAT DURING AN UNSPECIFIED PROCEDURE, THE DOCTOR PUNCTURED A HOLE, WITH A NEEDLE, ON THE DISTAL END BY THE TIP. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10778876 ↗
• MalfunctionSep 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE SERVICE CENTER WAS INFORMED THAT THE SCOPE WAS NOTED TO BE LEAKING FROM BOTH ENDS AND THERE WAS BITE DAMAGE AT THE TIP. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10583797 ↗
• MalfunctionSep 2, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THE DEVICE WAS RETURNED DUE TO A CRACK AT THE TIP. DURING ESTIMATION, IT WAS IDENTIFIED THAT THERE WAS NO ABILITY TO PASS THE SMALL BRUSH THROUGH THE BALLOON CHANNEL. NO PATIENT INJURY OCCURRED.

  Patient problems: No Patient Involvement

  MAUDE report 10486461 ↗
• MalfunctionJul 27, 2020Break; Break

  THE USER ALSO REPORTED THAT A NEW NURSE WAS BEING TRAINED ON HOW TO PUT THE BALLOON ON THE SCOPE AND THE NIPPLE PART BROKE IN THE BEGINNING WHEN SHE WAS ATTEMPTING TO PUT ON THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT AS THIS HAPPENED PRIOR TO A PROCEDURE. THERE WAS NO DAMAGE OR ABNORMALITIES OBSERVED PRIOR TO THE SCOPE BREAKING. THERE WAS NO METAL EXPOSED. THERE WERE NO ISSUES WITH THE BALLOON.

  Patient problems: No Patient Involvement

  MAUDE report 10326517 ↗
• MalfunctionJul 21, 2020Break; Component Missing; Break; Component Missing

  IT WAS REPORTED THAT DURING PREPARATION FOR USE, THE DEVICE WAS FOUND WITH CRACKED C BODY UNIT AND THE PROBE UNIT TIP WAS MISSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORT. NO USER IMPACT OR INJURY WAS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10301869 ↗
• MalfunctionJul 14, 2020Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT A REPROCESSING IN-SERVICE WAS NEEDED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273371 ↗
• MalfunctionJul 1, 2020Break; Break

  THE USER FACILITY REPORTED THAT THE TIP AT THE VERY END OF THE SCOPE IS BROKEN OFF. NO ADDITIONAL INFORMATION HAS BEEN OBTAINED.

  Patient problems: No Patient Involvement

  MAUDE report 10217746 ↗
• MalfunctionJun 25, 2020Break; Break

  THE USER FACILITY REPORTED THAT THEY WERE PERFORMING AN ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS) FOR BIOPSIES TO RULE OUT CANCER. THERE WAS A DELAY IN THE CASE WHILE TRYING TO REMOVE THE BROKEN PIECE, MAYBE AN EXTRA 30 MINUTES. THE TIP OF THE SCOPE THAT HOLDS THE BALLOON IS WHAT BROKE OFF, APPROXIMATELY 2MM. THE DOCTOR WAS ABLE TO REMOVE THE ENTIRE PIECE THAT WAS BROKEN OFF FROM THE PATIENT. THE PATIENT IS IN GOOD CONDITION, DISCHARGED HOME AFTER PROCEDURE. NO DEMOGRAPHICS WERE PROVIDED. THE SCOPE WAS INSPECTED PRIOR TO USE BY THE ENDO STAFF AND OLYMPUS REP.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 10196601 ↗
• MalfunctionJun 11, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT DURING REPROCESSING, THE DEVICE WAS OBSERVED TO HAVE HOLE INSIDE THE TRANSDUCER LUMEN. ACCORDING TO THE REPORTER, PRIOR TO THE REPROCESSING WHERE THE HOLE WAS DISCOVERED, THE DEVICE MALFUNCTIONED DURING A CASE. THE SAID MALFUNCTION OCCURRED AT THE END OF THE PROCEDURE. THE TYPE OF MALFUNCTION WAS NOT PROVIDED INCLUDING THE TYPE OF PROCEDURE BEING PERFORMED. THE INTENDED PROCEDURE ACCORDING TO THE REPORTER WAS COMPLETED WITH NO IMPACT OR HARM OR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10145439 ↗
• MalfunctionJun 10, 2020Material Puncture/Hole; Obstruction of Flow; Material Puncture/Hole; Obstruction of Flow

  THE USER FACILITY RETURNED THE DEVICE FOR SERVICE DUE BLOCKAGES AND RESTRICTIONS IN THE INSTRUMENT CHANNEL. THE USER FACILITY WAS CONTACTED TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT AND WAS INFORMED THAT THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10141163 ↗
• MalfunctionJun 5, 2020Break; Break

  OLYMPUS WAS INFORMED THAT THE DISTAL END BUTTON FELL OFF FROM THE DEVICE AND THE DISTAL TIP IS MISSING. THE CHANNEL IS STAINED BLACK AT THE TIP. IT WAS ALSO REPORTED THAT THE EVENT OCCURRED DURING REPROCESSING OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10125543 ↗
• MalfunctionJun 2, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT THE WHITE PLASTIC HAS A CHUNK BROKEN OFF [SIC]. IT WAS LATER DETERMINED BY THE MANUFACTURER THAT THE WHITE PLASTIC CHUNK REFERS TO THE ULTRASOUND PROBE UNIT ON THE TIP OF THE DISTAL END. NO ADVERSE EVENT OCCURRED RELATED TO THIS REPORTED DEVICE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10111592 ↗
• MalfunctionMay 13, 2020Material Puncture/Hole; Material Puncture/Hole

  OLYMPUS RECEIVED A COMPLAINT FROM THE USER FACILITY STATING THAT HOLES WERE FOUND IN THE SCOPE. THERE IS NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 10051624 ↗
• MalfunctionMay 12, 2020Material Fragmentation; Material Fragmentation

  OLYMPUS RECEIVED A COMPLAINT STATING THE DURING A CLEAN OUT BRONCHOSCOPY PROCEDURE, A PIECE OF A BLACK PLASTIC WAS FOUND IN THE PATIENT. THE CLEAN OUT PROCEDURE WAS PERFORMED AFTER AN ENDOBRONCHIAL ULTRASOUND (EBUS) CASE WAS PERFORMED ON THE PATIENT WITH A DIFFERENT SCOPE. THE EBUS WAS INITIALLY BEING PERFORMED FOR A SEPARATE REASON AND THE PATIENT HAD NO SYMPTOMS RELATED TO THE FOREIGN BODY NEITHER BEFORE OR AFTER THE CASE. THE FOREIGN MATERIAL WAS REMOVED DURING THE CLEAN OUT BRONCHOSCOPY. THE FOREIGN OBJECT WAS TESTED AND THE RESULTS OF TESTING IDENTIFIED THE OBJECT NON-HUMAN TISSUE. THE PATIENT HAD NO COMPLICATIONS OR INJURIES AFTER THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT REQUIRE ANY FOLLOW UP TREATMENT AS IT RELATES TO THE FOREIGN MATERIAL. THIS COMPLAINT CAPTURES 2 OF 2 COMPLAINTS FOR THIS REPORTED EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 10047427 ↗
• MalfunctionMay 11, 2020Break; Break

  OLYMPUS WAS INFORMED THAT THE TIP OF THE DEVICE BROKE OFF BUT BELIEVES THAT THE TIP DID NOT FALL INTO THE PATIENT. THE USER FACILITY STAFF FURTHER REPORTS THAT THIS MUST HAVE OCCURRED DURING REPROCESSING OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10045737 ↗