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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-260
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2024
Event Type  malfunction  
Manufacturer Narrative
The device was returned, and the evaluation also found that the angles were stuck, the plastic distal end cover was burnt, and the image was blurry due to the damage on the charged coupled device unit.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported, the bronchovideoscope image was flickering but the object was visible.The issue occurred during reprocessing.There were no reports of patient harm.
 
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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 965-8 520
JA   965-8520
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18875993
MDR Text Key337347264
Report Number9610595-2024-05147
Device Sequence Number1
Product Code EOQ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K023984
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBF-260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2024
Was the Report Sent to FDA? No
Date Manufacturer Received02/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2013
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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