MAUDE Adverse Event Report: AIZU OLYMPUS CO., LTD. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-HQ190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fungal Infection (2419)
Date of Event	11/10/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• MDR Report Key: 15950831
• Report Number: 2429304-2022-00165
• Device Sequence Number: 7356872
• Product Code: FDS
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2022
• Report Date (Section F): 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GIF-HQ190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/09/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 57 KG