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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE COLONOVIDEOSCOPE
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AIZU OLYMPUS CO., LTD. EVIS LUCERA ELITE COLONOVIDEOSCOPE Back to Search Results
Model Number CF-HQ290ZI
Device Problem Corroded (1131)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was observed that during the device evaluation, the colonovideoscope had an e315 scope error.There were no reports of patient involvement.
 
Manufacturer Narrative
The device was returned and the evaluation found no reportable malfunctions aside from the allegation reported in b5.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
EVIS LUCERA ELITE COLONOVIDEOSCOPE
Type of Device
COLONOVIDEOSCOPE
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 Key18780985
MDR Text Key336970592
Report Number9610595-2024-03973
Device Sequence Number1
Product Code FDF
Combination Product (y/n)N
Reporter Country CodeJA
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 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCF-HQ290ZI
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/12/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2016
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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