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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III BRONCHOVIDEOSCOPE
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AIZU OLYMPUS CO., LTD. EVIS EXERA III BRONCHOVIDEOSCOPE Back to Search Results
Model Number BF-P190
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was observed during the device inspection, that the bronchovideoscope plastic distal end was cracked and burnt.There were no reports of patient involvement.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
EVIS EXERA III 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 Key19215275
MDR Text Key341729902
Report Number9610595-2024-08933
Device Sequence Number1
Product Code EOQ
UDI-Device Identifier04953170434983
UDI-Public04953170434983
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K201758
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberBF-P190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2024
Was the Report Sent to FDA? No
Date Manufacturer Received04/16/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/20/2020
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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