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

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.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: 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
• MDR Text Key: 305178394
• Report Number: 2429304-2022-00165
• Device Sequence Number: 1
• Product Code: FDS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 57 KG