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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-H190
Device Problem Microbial Contamination of Device (2303)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The olympus scope was sent to an independent laboratory for culture testing and results are still pending.The investigation is ongoing and follow up with the customer is currently being performed.After culture testing, the device will be evaluated.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
Event Description
It was reported that the bronchovideoscope tested positive for an unexpected contamination.The issue was found during a routine culture of the scope.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.
 
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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 Key18713956
MDR Text Key335823023
Report Number9610595-2024-03291
Device Sequence Number1
Product Code EOQ
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K121959
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBF-H190
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/01/2024
Initial Date FDA Received02/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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