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

Model Number	GIF-1TH190
Medical Device Problem Codes	Contamination (1120); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Drug Resistant Bacterial Infection (4553)
Date of Event	08/23/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
This event is reported by the importer in mw 2429304 - 2023 - 00007.The device referenced in this report was returned to olympus for evaluation.Preliminary findings are reported.The investigation is ongoing.Physical evaluation of the returned device: there is fluid leakage from the biopsy channel/ the image was ok after aeration.The camera switch was misaligned.The up angulation was low.The control knob had play.The cover plastic and scratches with sharp edge.The adhesive rubber was cracked/discolored/sharp.The insertion tube had buckles below the boot.The control body had corrosion.The device was refurbished/restored back to olympus original factory specifications.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
The customer reports three patients who underwent procedures using one (or both) of two different gastroscopes tested positive for a rare strain of antibiotic resistant e.Coli.The customer is unsure if the patients were cross infected with the scopes.The customer reports 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.Patient three: the patient underwent an esophagogastroduodenoscopy (egd) with biopsy for the indication of acute hemorrhagic anemia; active gastrointestinal bleeding on two dates , 59 days apart with two different gastroscopes.The infection was diagnosed by blood culture on 2 dates 28 days apart.The patient was treated with cefiderocol.The patient¿s current condition is reported to be deceased.Date and cause of death have been requested and not yet provided.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 (1st scope used).Case with patient identifier (b)(6) reports patient three of three (2nd scope used).
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to b3.Information has been added that was inadvertently not included in the previous submissions.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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.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: 16161778
• Report Number: 9610595-2023-00762
• Device Sequence Number: 19089171
• 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): Unknown
• 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
• Date Returned to Manufacturer: 01/16/2023
• 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: 05/25/2023; 05/25/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 05/25/2023; 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: Required Intervention; Death; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 57 KG