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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 Problems Break (1069); Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was observed that during the device inspection, the bronchovideoscope exhibited a broken charged coupled device unit and the connecting tube had coating peeling.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 965-8 520
JA   965-8520
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18960192
MDR Text Key338443033
Report Number9610595-2024-06150
Device Sequence Number1
Product Code EOQ
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K023984
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
Report Date 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberBF-260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/26/2010
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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