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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE Back to Search Results
Model Number LTF-S190-5
Device Problems Device Alarm System (1012); No Display/Image (1183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was evaluated at olympus repair center.Olympus repair center could not reproduce the reported phenomenon.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined.Omsc surmised that this phenomenon was attributed to the failure of the ccd unit, the circuit board inside the scope connector, or the video system center.If significant additional information is received, this report will be supplemented.
 
Event Description
The user found that an error and a sandstorm were displayed on the endoscopic image.The device was returned to olympus repair center.Olympus repair center found that the error b30 (scope connection error) was displayed.There was no report of patient injury associated with this event.The user facility did not provide other detailed information.
 
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Brand Name
ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE
Type of Device
FLEX DEFLECTABLE VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key12485932
MDR Text Key280805590
Report Number8010047-2021-11870
Device Sequence Number1
Product Code GCJ
Combination Product (y/n)N
PMA/PMN Number
K080948
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial
Report Date 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberLTF-S190-5
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2021
Was the Report Sent to FDA? No
Date Manufacturer Received08/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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