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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 Image Display Error/Artifact (1304)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/18/2022
Event Type  malfunction  
Event Description
During a standard inspection of a customer returned asset, the evis exera iii gastrointestinal videoscope presented an e204 focus function error message.The customer did not report any problems associated with the device and there was no patient/user injury or harm reported to olympus.
 
Manufacturer Narrative
During the device evaluation, there were no additional findings.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
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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 Key14643346
MDR Text Key302061264
Report Number8010047-2022-09724
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,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 06/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
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 Manufacturer05/17/2022
Was the Report Sent to FDA? No
Date Manufacturer Received05/10/2022
Was Device Evaluated by Manufacturer? Yes
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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