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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA II BRONCHOVIDEOSCOPE
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AIZU OLYMPUS CO., LTD. EVIS EXERA II BRONCHOVIDEOSCOPE Back to Search Results
Model Number BF-1T180
Device Problems Thermal Decomposition of Device (1071); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/05/2024
Event Type  malfunction  
Manufacturer Narrative
The device was returned and the evaluation found that the distal end was dirty.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the bronchovideoscope had a leak on the bending section cover or distal sheath, and the plastic distal end cover had a burn.There were no reports of patient harm.
 
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Brand Name
EVIS EXERA II 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 Key18758551
MDR Text Key336002572
Report Number9610595-2024-03739
Device Sequence Number1
Product Code EOQ
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K061313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBF-1T180
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/07/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/05/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/17/2012
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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