Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III BRONCHOVIDEOSCOPE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AIZU OLYMPUS CO., LTD. EVIS EXERA III BRONCHOVIDEOSCOPE Back to Search Results
Model Number BF-1TH190
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 observed that during the device inspection, the bronchovideoscope connecting tube coating was observed to be peeling.There were no reports of patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key19213539
MDR Text Key341809022
Report Number9610595-2024-08904
Device Sequence Number1
Product Code EOQ
UDI-Device Identifier04953170335181
UDI-Public04953170335181
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K121959
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBF-1TH190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2024
Was the Report Sent to FDA? No
Date Manufacturer Received04/18/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/27/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-