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

Model Number GIF-HQ190

Device Problem Contamination (1120)

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.

Manufacturer Narrative

The device referenced in this report was not yet been returned to olympus for evaluation (although it is anticipated to be.The definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.This event has been reported by the importer on mdr# 2429304 - 2022 - 00165.

Manufacturer Narrative

This report is being supplemented to provide additional information based on results of third party testing, the device evaluation, and the legal manufacturer's final investigation.Correction to initial for information inadvertently left out.After the device was returned to olympus, it was sent out for additional testing.The third party test lab found staphylococcus epidermidis and rothia dentocariosa in the instrument/suction channel.Testing also found micrococcus luteus in the distal end.The device was evaluated where no abnormalities were found that could have led to the positive culture.An olympus borescope was used to inspect the condition of the biopsy and suction channel.Upon inspection, olympus noted light surface scratches and scrape marks on the wall of the biopsy channel.The borescope was inserted further and found more scrape marks throughout the biopsy channel.Olympus noted dents and scratches on the distal end cover, and cracks and pinholes along the bending section glue.In addition, the insulation at the connector cover was out of specification, there was an error code 204, the angulation was out of specification, there was a damaged connector and the customer label was peeling.However, these defects alone are not considered severe enough to cause a potential adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus reviewed reprocessing steps provided by the user, but found no obvious deviation from the instructions for use.Based on the results of the investigation, a root cause could not be determined.Based on the results of the investigation, the relationship between the positive culture, the patient infection, and the device cannot be confirmed.Growth of microorganisms was found through culture testing by the user and olympus after reprocessing.The root cause cannot be identified.The following is included in the device ifu: "warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Type of Device: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima 965-8 520; JA 965-8520
• Manufacturer (Section G): AIZU OLYMPUS CO., LTD.; 3-1-1 niiderakita; aizuwakamatsu-shi, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15951069
• MDR Text Key: 305236861
• Report Number: 9610595-2022-05189
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170436734
• UDI-Public: 04953170436734
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131780
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

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
• Device Catalogue Number: N3802941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 57 KG