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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-S190-5
Device Problem Poor Quality Image (1408)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2024
Event Type  malfunction  
Event Description
It was reported that the deflectable videoscope image was static.The issue occurred during preparation before use.The intended procedure was completed using a similar device.There were no reports of patient harm.
 
Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the deflectable videoscope image was static.The issue occurred during preparation before use.The intended procedure was completed using a similar device.There were no reports of patient harm.It was further reported that the deflectable videoscope exhibited a b30 scope communication error.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer¿s final investigation.Correction to b5 for information inadvertently left out of previous report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 10 years since the subject device was manufactured.The device was returned to olympus for inspection, and the reportable malfunction was confirmed.Inspection of the endoscope after disassembly observed a kink on the image sensor cable in the boot on the universal cord light guide connector side.It is presumed for the cause of the b30 scope communication error code and static image that a kink on the image sensor cable may have caused disconnection or short-circuit of the output signal cable, leading to the phenomenon of the irregular image.The kink on the image sensor cable may have been caused by application of strong external load to the image sensor cable due to load which exceeds assumption such as excessive twisting and bending.The event can be prevented by following the instructions for use: chapter 3 "reparation and inspection", section 3.8 "inspection of the endoscopic system".Based on the results of the investigation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.
 
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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 Key19135064
MDR Text Key341469132
Report Number9610595-2024-08163
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier04953170434648
UDI-Public04953170434648
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K201832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/18/2024
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 Health Professional
Device Model NumberLTF-S190-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/17/2024
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/14/2024
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/28/2014
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
VISERA ELITE VIDEO SYSTEM CENTER (OTV-S190)
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