Edge SD300BARecalls & reported problems
Covidien LP · Bronchoscope Adapter;For use with Olympus bronchoscopes · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521199507), received between Nov 27, 2018 and Nov 27, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Defective Device” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective Device1
Patient problems
- Unspecified Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2018Defective Device; Defective Device
ACCORDING TO THE REPORTER, THE BRONCHOSCOPY ADAPTOR REQUIRED EXCESSIVE FORCE TO REMOVE FROM THE BRONCHOSCOPE, WHICH CAUSED DAMAGE TO THE BRONCHOSCOPE, LOOSENING THE INSTRUMENT CHANNEL, ALLOWING BIOMATTER TO ACCUMULATE UNDER THE DEVICE'S O-RING, WHICH CANNOT BE CLEANED, DISINFECTED AND/OR REMOVED DURING REPROCESSING. IT ALLEGEDLY CONTRIBUTED TO A PATIENT INFECTION.
Patient problems: Unspecified Infection
MAUDE report 8107116 ↗
Other System, x-ray, tomography, computed devices
- ARTIS icono biplane 11327600Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls2 deaths55 reports
- ARTIS icono floor 11327700Siemens Healthcare GmbH · System, x-ray, tomography, computed15 recalls24 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, x-ray, tomography, computed13 recalls5 reports
- Spectral CTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed11 recalls3 reports
- Incisive CTPhilips Healthcare (Suzhou) Co., Ltd. · System, X-Ray, Tomography, Computed9 recalls20 reports
- Brilliance iCTPhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed8 recalls6 reports
- Revolution Apex EliteGE Medical Systems, L.L.C. · System, x-ray, tomography, computed8 recalls0 reports
- Brilliance CT Big BorePhilips Medical Systems Nederland B.V. · System, x-ray, tomography, computed7 recalls1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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