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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 Problems No Display/Image (1183); Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2024
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 reported the bronchovideoscope had a noisy image and black screen.There were no reports of patient harm.
 
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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 Key19008363
MDR Text Key339326339
Report Number9610595-2024-06717
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,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBF-Q170
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/15/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/13/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/18/2016
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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