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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. BRONCHOFIBERSCOPE
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AIZU OLYMPUS CO., LTD. BRONCHOFIBERSCOPE Back to Search Results
Model Number BF-PE2
Device Problems Peeled/Delaminated (1454); Failure to Clean Adequately (4048)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was observed during the device inspection, that the bronchofiberscope exhibited foreign material in bending section cover, the adhesive on the bending section cover, and connecting tube.The bending section cover also had peeling.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
BRONCHOFIBERSCOPE
Type of Device
BRONCHOFIBERSCOPE
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 Key19191430
MDR Text Key341510058
Report Number9610595-2024-08721
Device Sequence Number1
Product Code EOQ
UDI-Device Identifier04953170339974
UDI-Public04953170339974
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K023984
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 04/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberBF-PE2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/18/2024
Was the Report Sent to FDA? No
Date Manufacturer Received04/19/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/07/2018
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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