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

Model Number	GIF-1TH190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	10/15/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device referenced in this report was not 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# (b)(4).
Event or Problem Description
The customer reports three patients who underwent unspecified procedures using one of two different gastroscopes tested positive for a rate strain of antibiotic resistant e.Coli.The customer is unsure if the patients were cross infected with the scopes.Additional details regarding the patients and reported events have been requested.At this time, the only additional provided by the customer was that the scopes have been cultured by the facility.The cultures on both scopes have all come back negative, however, the scopes will be sent in for routine maintenance.Case with patient identifier (b)(6) reports patient one of three case with patient identifier (b)(6) reports patient two of three case with patient identifier (b)(6) reports patient three of three.
Event or Problem Description
Update: additional information provided by the customer: the procedure being performed was an esophagogastroduodenoscopy (egd) with clip for the indication of hematochezia.The infection was diagnosed 5 days after the procedure by blood culture.The patient was treated with iv antibiotics (cefiderocol).The patient's current condition is reported as deceased.Date and cause of death were not provided.Additional information has been requested.At this time, no additional information has been provided.
Additional Manufacturer Narrative
This report is being updated to report additional information provided by the customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the following non-reportable defects were observed: insufficient angulation, play on angulation control knob, dented plastic distal end cover, and bending section cover was cracked.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, a root cause of the reported event could not be determined.The olympus endoscopy support specialist (ess) confirmed that after observing the customer's reprocessing steps of the device, there were no deviations from the instructions for use (ifu).The user also confirmed that after performing culture testing of the device, the results were negative.Therefore, a relationship between the reported patient infection and the subject device could not be identified.This supplemental report includes a correction to d9 to provide information that was inadvertently not included on the initial medwatch.An update has been made to h3.Also, additional information has been added to d8 and h4.Olympus will continue to monitor field performance for this device.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: 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: 15846876
• Report Number: 9610595-2022-04445
• Device Sequence Number: 5332310
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K112680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/25/2023

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-1TH190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 12/20/2022; 05/17/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 01/19/2023; 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 155 KG