EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F (UDI 04953170355608)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170355608), received between Dec 23, 2020 and Sep 16, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2021Device Reprocessing Problem; Device Reprocessing Problem

  THE ENDOSCOPY SUPPORT SPECIALIST (ESS) REPORTED THAT DURING AN ONSITE IN-SERVICE A COMPLETE TOUR OF THE PROCEDURE ROOM, REPROCESSING AREA AND STORAGE CABINETS WAS COMPLETED WITH FACILITY¿S ENDOSCOPY AND RESPIRATORY THERAPY (RT) STAFF. THE ESS OBSERVED THAT AN EBUS SCOPE HAD BEEN IMPROPERLY REPROCESSED AND NOTED A PIECE OF A BALLOON AND A DRIED SUBSTANCE ON THE S-BODY (DISTAL TIP) OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481744 ↗
• MalfunctionApr 6, 2021Component Missing; Component Missing

  A USER FACILITY REPORTED TO OLYMPUS THAT THE DISTAL END OF THE SCOPE WAS MISSING A SMALL PIECE. THE PROBLEM, AS REPORTED TO OLYMPUS, OCCURRED AND WAS FIRST IDENTIFIED DURING REPROCESSING OF THE SCOPE. THERE WAS NO PATIENT INJURY OR HARM, ASSOCIATED WITH THE PROBLEM, REPORTED TO OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11624647 ↗
• MalfunctionFeb 26, 2021Device Reprocessing Problem; Material Separation; Device Reprocessing Problem; Material Separation

  THE SERVICE CENTER WAS INFORMED DURING REPROCESSING THE SCOPE¿S WORKING CHANNEL WAS COMING APART WITH DEBRIS NOTED INSIDE THE CHANNEL. THERE WAS ALSO A RED DYE LIKE SUBSTANCE IN THE CHANNEL. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 11385756 ↗
• MalfunctionDec 23, 2020Material Separation; Material Separation

  IT WAS REPORTED, THAT THE ROUND DISTAL END OF THE EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE SEPARATED. NO PATIENT HARM WAS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11067280 ↗