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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
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AIZU OLYMPUS CO., LTD. ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE Back to Search Results
Model Number LTF-190-10-3D
Device Problems Defective Component (2292); Communication or Transmission Problem (2896)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2024
Event Type  malfunction  
Event Description
It was observed that during the device evaluation, the videoscope exhibited error code b30 due to a defective charged coupled device unit.There were no reports of patient involvement.
 
Manufacturer Narrative
The device was returned and the evaluation found no reportable malfunctions aside from the reportable malfunction in the b5.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE
Type of Device
FLEX 3D DEFLECTABLE VIDEOSCOPE
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 Key18743431
MDR Text Key336881140
Report Number9610595-2024-03557
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K123365
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,Followup
Report Date 03/19/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberLTF-190-10-3D
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/02/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
CV-190 (VIDEO SYSTEM CENTER).
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