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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BRONCHOVIDEOSCOPE
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AIZU OLYMPUS CO., LTD. BRONCHOVIDEOSCOPE Back to Search Results
Model Number BF-Q170
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/29/2024
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 evaluation, the bronchovideoscope exhibited black screen during down angulation due to defective charged couple device unit.There were no reports of patient involvement.
 
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Brand Name
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 Key18921822
MDR Text Key337875121
Report Number9610595-2024-05677
Device Sequence Number1
Product Code EOQ
UDI-Device Identifier04953170342912
UDI-Public04953170342912
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K121959
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 03/18/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberBF-Q170
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CV-170VIDEO SYSTEM CENTER.
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