EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE UC180F (UDI 04953170355592)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170355592), received between Oct 5, 2020 and Aug 8, 2024 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED, THE BRONCHOFIBERVIDEOSCOPE HAD A RIDGE IN THE TOOL CHANNEL THAT NEEDLES WERE GETTING CAUGHT IN. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944770 ↗
• MalfunctionMay 3, 2021Material Separation; Material Separation

  IT WAS REPORTED, THE BALL ON THE TIP OF THE EVIS EXERA II ULTRASONIC BRONCHOFIVERVIDEOSCOPE SEPARATED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11760824 ↗
• MalfunctionDec 7, 2020Device Reprocessing Problem; Device Reprocessing Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING AN IN-SERVICE AT THE USER FACILITY WITH AN ENDOSCOPY SUPPORT SPECIALIST (ESS) IT WAS OBSERVED THAT STAFF WAS NOT USING AIR/WATER CHANNEL CLEANING ADAPTOR AND WERE NOT FLUSHING THE AUXILIARY CHANNEL OF THE SCOPES AT BEDSIDE. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INFECTION OR POSITIVE DEVICE CULTURE.

  Patient problems: No Patient Involvement

  MAUDE report 10962284 ↗
• MalfunctionOct 16, 2020Device Reprocessing Problem; Device Reprocessing Problem

  THE SERVICE CENTER WAS INFORMED THAT DURING AN ONSITE REPROCESSING IN-SERVICE WITH AN ENDOSCOPY SUPPORT SPECIALIST (ESS), IT WAS NOTED THAT SCOPE SUCTION WAS NOT BEING PERFORMED. THE ESS REPORTED THAT THE FACILITY¿S SUCTIONING IN THE REPROCESSING AREA HAD BEEN REMOVED MONTHS AGO AND THERE IS NO SUCTION FOR ANY SCOPES BEING REPROCESSED. THERE WAS NO PATIENT INVOLVEMENT, PATIENT INFECTION OR DEVICE POSITIVE CULTURE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10692994 ↗
• MalfunctionOct 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT THERE WAS AN ISSUE WITH THE AIR/WATER LEAKAGES OR FLUID INVASION. THE DEVICE FAILED THE LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10626444 ↗