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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-HQ190
Device Problem Mechanical Problem (1384)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has been returned to olympus for evaluation, but has not yet been fully examined/tested.The definitive cause of the customer's experience can not be determined at this time.This report will be updated upon completion of the investigation and should any additional relevant information become available.
 
Event Description
It is reported that an olympus evis exera iii gastrointestinal videoscope was found to have insertion tube defects and the angulation becomes locked and can not be disengaged.It was also noted that the up and down dial is loose.There was no patient involvement.
 
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Brand Name
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Type of Device
GASTROINTESTINAL VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key10819800
MDR Text Key224627932
Report Number8010047-2020-08763
Device Sequence Number1
Product Code FDS
UDI-Device Identifier04953170305276
UDI-Public04953170305276
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/10/2020
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 NumberGIF-HQ190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/06/2020
Initial Date FDA Received11/10/2020
Was Device Evaluated by Manufacturer? No
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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