EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 (UDI 04953170308208)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170308208), received between Mar 10, 2020 and Mar 10, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Reprocessing Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SERVICE CENTER WAS INFORMED THAT FOUR PATIENTS CONTRACTED A CYTOMEGALOVIRUS INFECTION AFTER UNDERGOING A PROCEDURE WITH THE FACILITY¿S BRONCHOSCOPES. THE USER FACILITY REPORTED THAT THESE WERE INPATIENTS IN THE FACILITY¿S BURN OR RESPIRATORY CARE UNIT. THE PATIENT SAMPLES WERE SENT AN INDEPENDENT LABORATORY AND CULTURED POSITIVE. AS A RESULT, THE USER FACILITY ACQUIRED A SAMPLE OF THE DISINFECTANT FLUSHED FROM THE SCOPE; HOWEVER, THE CULTURE RESULTS ARE UNKNOWN AT THIS. THE SAMPLES FROM THE SCOPES ARE BEING RETAINED AT THE FACILITY AND REFRIGERATED. THE SCOPES WERE TAKEN OUT SERVICE AT THAT TIME; HOWEVER MAY HAVE BEEN PUT BACK INTO SERVICE DUE TO LIMITED INVENTORY. THE PATIENT¿S COURSE OF TREATMENT IS UNKNOWN. THIS IS 1 OF 8 REPORTS.

  Patient problems: Viral Infection

  MAUDE report 9813216 ↗
• InjuryMar 10, 2020Device Reprocessing Problem; Microbial Contamination of Device

  THE SERVICE CENTER WAS INFORMED THAT FOUR PATIENTS CONTRACTED A CYTOMEGALOVIRUS INFECTION AFTER UNDERGOING A PROCEDURE WITH THE FACILITY¿S BRONCHOSCOPES. THE USER FACILITY REPORTED THAT THESE WERE INPATIENTS IN THE FACILITY¿S BURN OR RESPIRATORY CARE UNIT. THE PATIENT SAMPLES WERE SENT AN INDEPENDENT LABORATORY AND CULTURED POSITIVE. AS A RESULT, THE USER FACILITY ACQUIRED A SAMPLE OF THE DISINFECTANT FLUSHED FROM THE SCOPE; HOWEVER, THE CULTURE RESULTS ARE UNKNOWN AT THIS. THE SAMPLES FROM THE SCOPES ARE BEING RETAINED AT THE FACILITY AND REFRIGERATED. THE SCOPES WERE TAKEN OUT SERVICE AT THAT TIME; HOWEVER MAY HAVE BEEN PUT BACK INTO SERVICE DUE TO LIMITED INVENTORY. THE PATIENT¿S COURSE OF TREATMENT IS UNKNOWN. THIS IS 2 OF 8 REPORTS. AS PART OF OUR INVESTIGATION OF THIS REPORT, AN OLYMPUS ENDOSCOPY SUPPORT SPECIALIST (ESS) WAS DISPATCHED TO THE USER FACILITY TO ASSESS THEIR REPROCESSING PRACTICES AND TO PROVIDE REPROCESSING TRAINING IF NECESSARY. TO DATE, THE ESS VISIT HAS NOT BEEN FINALIZED. THE SCOPE IS BEING RETAINED AT THE USER FACILITY AT THIS TIME. AN INVESTIGATION IS ONGOING TO OBTAIN ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. THIS REPORT IS TO ACCOUNT FOR PATI

  Patient problems: Bacterial Infection

  MAUDE report 9813050 ↗