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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 Problems No Display/Image (1183); Electrical Shorting (2926)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2022
Event Type  malfunction  
Event Description
Customer reported no image on the device, stated it seems to have a short in it.Customer could not remember the code.The issue occurred at preparation for use.No harm was reported.No patient harm, no user injury reported.
 
Manufacturer Narrative
The subject device was received and evaluated.Device evaluation has confirmed the customer reported issue of no image.Device evaluation found no image , only lines were visible.Image noted to be intermittent/distorted.Additionally, leaking on light guide cover glass tip was observed.Due to cut/hole leaking on a-rubber (bending section) was observed.Switches found to be all functional.Investigation is ongoing.This report will be supplemented accordingly following investigation.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to e2, e3, g2 (health professional was inadvertently left off the initial report).The device history record was unable to be reviewed for this device.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it is likely that the reportable phenomenon's occurred due to the conduction failure of circuit board inside video connector, causing water to invade the device from leaked location.The event can be prevented by following the instructions for use: "operation manual: important information ¿ please read before use: precaution for disappeared or frozen endoscopic image." 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
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key16251345
MDR Text Key308240494
Report Number9610595-2023-01391
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier04953170310355
UDI-Public04953170310355
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201832
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/26/2023
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 Manufacturer01/12/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/03/2023
Initial Date FDA Received01/26/2023
Supplement Dates Manufacturer Received05/09/2023
Supplement Dates FDA Received05/26/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/28/2018
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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