EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F (UDI 04953170340116)Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 04953170340116), received between Jun 22, 2020 and Jan 5, 2026 — classified as 6 injuries, 37 malfunctions.

The most frequently reported specific device problem is “No Display/Image” (21 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-2491-2023 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Poor Quality Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE IMAGE WAS DARK AND THERE WAS A LINE ACROSS THE IMAGE OF THE BRONCHOFIBERVIDEOSCOPE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23956538 ↗
• MalfunctionDec 22, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED A FLICKERING IMAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23873618 ↗
• MalfunctionDec 17, 2025Image Display Error/Artifact; Poor Quality Image; Image Display Error/Artifact; Poor Quality Image

  CUSTOMER REPORTED " MINOR ENDOSCOPE LEAK ". THE ISSUE WAS FOUND DURING REPROCESSING. DEVICE INSPECTION FOUND IMAGE-NOISY, GRAINY. THERE WAS NO PATIENT INVOLVEMENT IN THIS REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23825724 ↗
• MalfunctionDec 16, 2025No Display/Image; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED NO IMAGE (BLACK IMAGE). THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23824397 ↗
• MalfunctionAug 22, 2024No Display/Image; No Display/Image

  IT WAS OBSERVED, DURING THE DEVICE INSPECTION. THAT THE BROCHOVIDEOSCOPE EXHIBITED NO IMAGE-UNRESTORABLE, NO ERROR CODE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20038863 ↗
• MalfunctionJul 10, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED THAT, DURING REPROCESSING, THE BRONCHOFIBERVIDEOSCOPE TESTED POSITIVE FOR AN UNEXPECTED CONTAMINATION. THE USER DID NOT REPORT ANY CONTAMINATION OR ANY OTHER SERIOUS DETERIORATION IN STATE OF HEALTH OF ANY PERSON, TO WHICH THE SCOPE COULD HAVE BEEN A CONTRIBUTORY CAUSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19712016 ↗
• InjuryJun 10, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT DURING A BRONCHOSCOPIC PROCEDURE (ON A 3-YEAR-OLD PATIENT WEIGHING 16.4 KILOGRAMS), THE BRONCHOVIDEOSCOPE PRODUCED A COMPLETE BLACKOUT AND NO IMAGE COULD BE PRODUCED. THE EVENT OCCURRED DURING PREPARATION FOR USE WHILE THE PATIENT WAS UNDER ANESTHESIA. THE PROCEDURE WAS DELAYED BY 30 MINUTES AND COMPLETED BY REPLACING WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505685 ↗
• InjuryJun 5, 2024No Display/Image; No Display/Image

  IT WAS REPORTED FOR A BRONCHOFIBERVIDEOSCOPE, THE IMAGE DID NOT APPEAR AND THERE WAS A COMPLETE BLACK OUT OF THE SCREEN. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19466562 ↗
• MalfunctionApr 30, 2024Poor Quality Image; Poor Quality Image

  IT WAS REPORTED THAT THE IMAGE OF THE BRONCHOFIBERVIDEOSCOPE WAS NOT CLEAR. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215807 ↗
• MalfunctionFeb 5, 2024No Display/Image; No Display/Image

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED NO IMAGE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18645862 ↗
• MalfunctionJan 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED PEELING FROM THE COATING OF THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588943 ↗
• MalfunctionJan 26, 2024Peeled/Delaminated; Peeled/Delaminated

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE BRONCHOFIBERVIDEOSCOPE EXHIBITED PEELING FROM THE COATING OF THE CONNECTING TUBE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588723 ↗
• MalfunctionJan 26, 2024No Display/Image; No Display/Image

  IT WAS REPORTED THAT THE BRONCHOFIBERVIDEOSCOPE IMAGE WAS BLACK. THE ISSUE OCCURRED DURING A PREPARATION FOR USE OF A THERAPEUTIC AND DIAGNOSTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS A 5 MINUTE WHILE NEW SCOPE WAS OBTAINED. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18587589 ↗
• MalfunctionJan 24, 2024No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE BRONCHOFIBER VIDEOSCOPE SEEMED LIKE IT GOT FLOODED. THE IMAGE WAS BLACK. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18572803 ↗
• MalfunctionJan 2, 2024No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA BRONCHOFIBERVIDEOSCOPE IMAGE DOES NOT WORK INTERMITTENTLY AND HAD WATER BUBBLES ON IT. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432847 ↗
• MalfunctionDec 21, 2023No Display/Image; No Display/Image

  THE CUSTOMER INITIALLY REPORTED TO OLYMPUS, THE IMAGE IS COMPROMISED USING THE BRONCHOFIBERVIDEOSCOPE; VISION IS NO GOOD. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM. THE CUSTOMER LATER CLARIFIED THE EVENT DETAILS AND REPORTED THAT THE STAFF COMPLAINED THERE WAS NO PICTURE DURING SET-UP OF THE SCOPE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18372068 ↗
• MalfunctionDec 5, 2023Communication or Transmission Problem; Communication or Transmission Problem

  ADDITIONAL INFORMATION RECEIVED: THE DEVICE WAS NOT YET USED IN PROCEDURE, SINCE FAULT WAS NOTICED WHILE PREPARING FOR USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266178 ↗
• MalfunctionNov 16, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE BRONCHOFIBERVIDEOSCOPE HAD A BITE MARK AT THE TOP PORTION OF SCOPE AND A NO IMAGE ISSUE: THE AUDIO/VISUAL CONNECTION WAS NOT WORKING CORRECTLY. THE ISSUE WAS FOUND AT REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18146549 ↗
• MalfunctionSep 21, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THE EVIS EXERA BRONCHOFIBERVIDEOSCOPE EXHIBITED AN IMAGE ISSUE DURING PREPARATION FOR USE. THE FACILITY FINISHED THE PROCEDURE WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17788003 ↗
• MalfunctionSep 12, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE EVIS EXERA BRONCHOFIBERVIDEOSCOPE HAD NUMEROUS BROKEN FIBERS. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731228 ↗
• InjuryMay 11, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT ERROR CODES INDICATING A SCOPE COMMUNICATION ERROR WERE DETECTED DURING A FLEXIBLE BRONCHOSCOPY WITH BRONCHOALVEOLAR LAVAGE WHILE USING AN EVIS EXERA III XENON LIGHT SOURCE. AN EVIS EXERA III VIDEO SYSTEM CENTER AND AN EVIS EXERA BRONCHOFIBERVIDEOSCOPE WERE ALSO USED AT THAT TIME. THE PROCEDURE WAS DELAYED FOR 45 MINUTES WITH THE PATIENT UNDER SEDATION, PROLONGING TESTING AND DELAYING CARE OF A CRITICALLY ILL PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SCOPE AND ANOTHER TRAVEL CART WAS MADE AVAILABLE IN CASE THE EVENT OCCURRED AGAIN. THERE WAS NO FURTHER HARM REPORTED. THE CUSTOMER CONFIRMED THAT THE SCOPE AND VIDEO PROCESSOR WERE USED AGAIN IN ANOTHER PROCEDURE WITH NO ISSUES NOTED. ONLY THE LIGHT SOURCE WAS RETURNED TO OLYMPUS. SINCE THE ROOT CAUSE OF THE REPORTED MALFUNCTION THAT CAUSED THE DELAY WAS NOT KNOWN, ALL THREE DEVICES USED IN THE PROCEDURE ARE BEING REPORTED. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS: (B)(6) - LIGHT SOURCE. (B)(6) - VIDEO PROCESSOR. (B)(6) - BRONCHOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915259 ↗
• InjuryMay 11, 2023Communication or Transmission Problem; Communication or Transmission Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT ERROR CODES INDICATING A SCOPE COMMUNICATION ERROR WERE DETECTED DURING A FLEXIBLE BRONCHOSCOPY WITH BRONCHOALVEOLAR LAVAGE WHILE USING AN EVIS EXERA III XENON LIGHT SOURCE. AN EVIS EXERA III VIDEO SYSTEM CENTER AND AN EVIS EXERA BRONCHOFIBERVIDEOSCOPE WERE ALSO USED AT THAT TIME. THE PROCEDURE WAS DELAYED FOR 45 MINUTES WITH THE PATIENT UNDER SEDATION, PROLONGING TESTING AND DELAYING CARE OF A CRITICALLY ILL PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT SCOPE AND ANOTHER TRAVEL CART WAS MADE AVAILABLE IN CASE THE EVENT OCCURRED AGAIN. THERE WAS NO FURTHER HARM REPORTED. THE CUSTOMER CONFIRMED THAT THE SCOPE AND VIDEO PROCESSOR WERE USED AGAIN IN ANOTHER PROCEDURE WITH NO ISSUES NOTED. ONLY THE LIGHT SOURCE WAS RETURNED TO OLYMPUS. SINCE THE ROOT CAUSE OF THE REPORTED MALFUNCTION THAT CAUSED THE DELAY WAS NOT KNOWN, ALL THREE DEVICES USED IN THE PROCEDURE ARE BEING REPORTED. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS: (B)(6) - LIGHT SOURCE, (B)(6) - VIDEO PROCESSOR, (B)(6) - BRONCHOSCOPE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16913075 ↗
• MalfunctionApr 22, 2023No Display/Image; No Display/Image

  IT WAS REPORTED THE DEVICE FAILED LEAK TEST. DAMAGE AT THE TIP OF THE INSERTION TUBING WAS OBSERVED. THE ISSUE WAS FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED ISSUE. NO HARM WAS REPORTED. NO USER INJURY WAS REPORTED. DEVICE EVALUATION FOUND NO IMAGE . THIS REPORT IS BEING SUBMITTED DUE TO THE FINDING OF NO IMAGE IDENTIFIED DURING DEVICE RETURN EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16792735 ↗
• MalfunctionApr 20, 2023No Display/Image; Display or Visual Feedback Problem; No Display/Image; Display or Visual Feedback Problem

  THE CUSTOMER REPORTED TO OLYMPUS, THE EVIS EXERA BRONCHOFIBERVIDEOSCOPE HAD A DARK SCREEN AND COULD NOT SEE OUT OF IT. ADDITIONALLY, IT WAS REPORTED THAT THE INSERTION TUBE WAS DAMAGED/ CRUSHED THROUGHOUT. THERE WAS NO PATIENT/USER HARM OR INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782132 ↗
• MalfunctionMar 31, 2023No Display/Image; No Display/Image

  THE CUSTOMER REPORTED TO OLYMPUS THE EVIS EXERA BRONCHOFIBERVIDEOSCOPE INSERTION PORTION WAS DAMAGED. INSPECTION AND TESTING OF THE RETURNED DEVICE FOUND NO IMAGE WAS BEING PRODUCED BY THE DEVICE. THERE WERE NO REPORTS OF PATIENT HARM. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16656410 ↗