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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA BRONCHOVIDEOSCOPE
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AIZU OLYMPUS CO., LTD. EVIS LUCERA BRONCHOVIDEOSCOPE Back to Search Results
Model Number BF-F260
Device Problems No Display/Image (1183); Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2024
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus for evaluation.The device evaluation found the bending cover had leakage and the label on the suction connector was worn slightly.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
 
Event Description
It was observed that during the device evaluation, the bronchovideoscope exhibited the screen would black out due to a defective charged coupled device.There were no reports of patient involvement.
 
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Brand Name
EVIS LUCERA BRONCHOVIDEOSCOPE
Type of Device
BRONCHOVIDEOSCOPE
Manufacturer (Section D)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA  965-8520
Manufacturer (Section G)
AIZU OLYMPUS CO., LTD.
3-1-1 niiderakita
aizuwakamatsu-shi, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18646197
MDR Text Key335313579
Report Number9610595-2024-02472
Device Sequence Number1
Product Code EOQ
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/04/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberBF-F260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2024
Was the Report Sent to FDA? No
Date Manufacturer Received02/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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