EVIS EXERA II BRONCHOVIDEOSCOPE OLYPUS BF TYPE P180 (UDI 04953170308192)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 04953170308192), received between Jul 16, 2021 and Aug 26, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (30 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-2493-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Corroded

  The customer returned the BRONCHOVIDEOSCOPE to the service center for a separate issue. During the device analysis, the investigator indicated the connecting tube had corrosion. There was no patient involvement.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50456827 ↗
• MalfunctionAug 25, 2026Device Reprocessing Problem; Corroded; Improper Flow or Infusion

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50436483 ↗
• MalfunctionAug 5, 2026Corroded

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50142805 ↗
• MalfunctionJul 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50067628 ↗
• MalfunctionMar 31, 2026Suction Failure

  THE BRONCHOVIDEOSCOPE WAS RETURNED TO THE SERVICE CENTER WITH A REPORT OF A LEAKING BIOPSY CHANNEL. THIS DOES NOT INDICATE AN MDR REPORTABLE EVENT. HOWEVER, MDR REPORTABLE FAILURE WAS FOUND DURING TESTING AT THE SERVICE CENTER. DURING INSPECTION OF THE DEVICE, IT WAS FOUND THAT THE SUCTION VOLUME DID NOT MEET THE STANDARD VALUE DUE TO DAMAGE ON THE CHANNEL TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741660 ↗
• MalfunctionJan 6, 2026Erratic or Intermittent Display

  IT WAS OBSERVED DURING THE DEVICE EVALUATION, THAT THE BRONCHOVIDEOSCOPE DISPLAYED A NOISY IMAGE DUE TO DAMAGE ON CCD UNIT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23986466 ↗
• MalfunctionDec 8, 2025Melted; Melted

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SCOPE EXHIBITED BURN MARKS ON DISTAL END PROBE COVER (C-COVER). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23737046 ↗
• MalfunctionAug 21, 2025No Display/Image; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED A BLACKOUT WHEN THE POWER WAS TURNED ON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22865954 ↗
• MalfunctionJul 24, 2025Material Discolored; Material Deformation; Sharp Edges; Material Discolored; Material Deformation; Sharp Edges

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOVIDEOSCOPE EXHIBITED DAMAGE ON BENDING TUBE, METAL PART IS STICKING OUT FROM BREAKAGE ON A-RUBBER) AND CORROSION ON THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22601991 ↗
• MalfunctionMay 7, 2025No Display/Image; Peeled/Delaminated; No Display/Image; Peeled/Delaminated

  IT WAS REPORTED, THE BRONCHOVIDEOSCOPE EXHIBITED NO IMAGE. THE ISSUE OCCURRED DURING SERVICE/MAINTENANCE (NOT IN A CLINICAL SETTING). THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21975736 ↗
• MalfunctionMar 28, 2025No Display/Image; No Display/Image

  IT WAS REPORTED THAT THERE WAS NO IMAGE ON THE SUBJECT DEVICE. THIS OCCURRED DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21724077 ↗
• MalfunctionOct 28, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING PREPARATION FOR USE IN A DIAGNOSTIC BRONCHOSCOPY PROCEDURE. THERE WAS NO DELAY, AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20548651 ↗
• MalfunctionAug 26, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  IT WAS OBSERVED THAT DURING THE DEVICE INSPECTION, THE BRONCHOVIDEOSCOPE EXHIBITED BURNED PLASTIC DISTAL END COVER AROUND INSTRUMENT CHANNEL. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065213 ↗
• MalfunctionJul 25, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE EXHIBITED PEELING OF THE COATING ON THE INSERTION TUBE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19827079 ↗
• MalfunctionJul 3, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED DURING THE DEVICE INSPECTION, THAT THE BRONCHOVIDEOSCOPE INSERTION TUBE EXHIBITED EXCESSIVE PEELING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665724 ↗
• MalfunctionMay 2, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THE ISSUE OCCURRED DURING AN UNSPECIFIED EVENT. THERE WAS NO REPORT OF DELAY, THE PATIENT WAS NOT UNDER ANESTHESIA. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19234340 ↗
• MalfunctionMar 23, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT AFTER THE BRONCHOVIDEOSCOPE WAS PLUGGED IN AND TURNED ON THE IMAGE WENT FUZZY, THEN BLACK AND NO IMAGE RETURNED. IT WAS VERIFIED THAT WITH A DIFFERENT SCOPE THE MACHINE WORKS PROPERLY. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A BRONCHOALVEOLAR LAVAGE PROCEDURE THAT WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO DELAY REPORTED, AND NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18966336 ↗
• MalfunctionMar 14, 2024No Display/Image; No Display/Image

  IT WAS REPORTED, THE BRONCHOVIDEOSCOPES IMAGE WAS NOT VISIBLE AT ALL WITH A BLACK SCREEN. THE ISSUE OCCURRED DURING PREPARATION FOR A THERAPEUTIC BRONCHOSCOPY. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITH NO DELAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18903322 ↗
• MalfunctionJan 23, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOVIDEOSCOPE HAD NO IMAGE. THE ISSUE WAS FOUND DURING PREPARATION FOR USE FOR AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO DELAY IN THE PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18563318 ↗
• MalfunctionNov 30, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THERE WAS NO IMAGE AFTER TURNING ON THE COMPUTER WHEN USING THE BRONCHOVIDEOSCOPE DURING A DIAGNOSTIC TRACHEOSCOPY PROCEDURE. THE DEVICE WAS COMPLETED USING A SIMILAR DEVICE. IT WAS REPORTED THAT AFTER REPLACING THE VIDEO SYSTEM CENTER, THE FAILURE DID NOT REOCCUR. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18235378 ↗
• MalfunctionNov 15, 2023No Display/Image; No Display/Image

  IT WAS REPORTED TO OLYMPUS, THAT THE EVIS EXERA II BRONCHOVIDEOSCOPE DID NOT DISPLAY IMAGE AND THE ENTIRE SCREEN WAS BLACK. THE ISSUE WAS FOUND DURING INSPECTION FOR USE FOR A DIAGNOSTIC ENDOBRONCHIAL ULTRA SOUND AND IT WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18144857 ↗
• MalfunctionOct 31, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA II BRONCHOVIDEOSCOPE HAD A BLACK SCREEN. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18043915 ↗
• MalfunctionOct 30, 2023No Display/Image; No Display/Image

  THE OLYMPUS FIELD SERVICE ENGINEER REPORTED, DURING ON SITE TROUBLESHOOTING, GENERATION OF NOISE WAS SEEN ON MONITOR WHEN BRONCHOVIDEOSCOPE WAS CONNECTED TO 190 SYSTEM. FLUID INVASION WAS FOUND AT ELECTRICAL CONNECTORS AND WATER-RESISTANCE CAP. ELECTRICAL CONNECTOR WAS CLEANED AND DRIED, THEN RECONNECTED TO 190 SYSTEM, NO IMAGE WAS SHOWN (BLACK SCREEN). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035340 ↗
• MalfunctionOct 5, 2023Dent in Material; Dent in Material

  IT WAS REPORTED THAT THE PATIENT BIT DOWN ON THE BRONCHOVIDEOSCOPE IN MULTIPLE PLACES DURING THE PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17883040 ↗
• MalfunctionOct 2, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THE EVIS EXERA II BRONCHOVIDEOSCOPE, IMAGE PROBLEM, NO CONTACT TAKING PICTURES. THE ISSUE OCCURRED DURING REPROCESSING. THE PROCEDURE WAS UNKNOWN. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND THAT THERE WAS NO IMAGE. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTIONS FOUND DURING THE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17855252 ↗