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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-TE2
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was observed that during the device inspection, the bronchofiberscope exhibited forceps channel port was shaved.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.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 (thirteen) years since the subject device was manufactured.Based on the results of the investigation, it is likely the following led to the malfunction: it is presumed that the coiled shaft of cleaning brush contacted with biopsy channel port.Grounds for presumption were the following.- the endo therapy accessories were difficult to contact with biopsy channel port because biopsy valve was attached to the port at procedure.Coiled shaft of cleaning brush may have contacted with biopsy channel port because biopsy valve was detached at reprocessing.The event can be detected by following the instructions for use which state: operation manual, preparation and inspection, inspection of the endoscope: "inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, peeling, scratching, holes, sagging, transformation, bends, adhesion of foreign body, dropout of parts, any protruding objects or other irregularities".Olympus will continue to monitor field performance for this device.
 
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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
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19201747
MDR Text Key341383895
Report Number9610595-2024-08836
Device Sequence Number1
Product Code EOQ
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,Followup
Report Date 05/23/2024
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 Other
Device Model NumberBF-TE2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/22/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/24/2024
Initial Date FDA Received04/29/2024
Supplement Dates Manufacturer Received05/22/2024
Supplement Dates FDA Received05/23/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/23/2010
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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