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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
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AIZU OLYMPUS CO., LTD. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE Back to Search Results
Model Number LTF-S190-10
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 evaluation, the flex deflectable videoscope exhibited peeling of the adhesive around the objective lens.There were no reports of patient involvement.
 
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Brand Name
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
Type of Device
FLEX 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 965-8 520
JA   965-8520
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19003689
MDR Text Key339117464
Report Number9610595-2024-06644
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier04953170434662
UDI-Public04953170434662
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111425
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 03/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberLTF-S190-10
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/21/2024
Was the Report Sent to FDA? No
Date Manufacturer Received03/27/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured04/25/2020
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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