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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
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AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-HQ190
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fungal Infection (2419)
Event Date 11/10/2022
Event Type  Injury  
Event Description
The customer reports, six days after an upper gi endoscopy with peg-tube placement (for nutritional support) using an evis exera ii gastrointestinal videoscope, candida auris was identified in the patient¿s blood culture. The customer could not report how the infection was treated, as the patient had already been discharged to home with hospice care. The patient was not placed on hospice care due to the infection, but rather due to underlying pathology/co-morbidities. The patient¿s current condition was reproted as ¿assumed death¿, although this could not be verified by the customer and no date of death could be provided. The patient did not have diagnosed urosepsis on admission. It is unknown if the patient was colonized with an organism prior to the procedure. Routine testing for candida auris is not currently conducted at the facility.
 
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Brand NameEVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Type of DeviceGASTROINTESTINAL VIDEOSCOPE
Manufacturer (Section D)
AIZU OLYMPUS CO., LTD.
1-1 niiderakita
aizuwakamatsu-shi, fukushima 965-8 520
JA 965-8520
MDR Report Key15950831
MDR Text Key305178394
Report Number2429304-2022-00165
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/10/2022,12/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberGIF-HQ190
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date11/10/2022
Event Location Hospital
Date Report to Manufacturer11/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/09/2022 Patient Sequence Number: 1
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