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

Model Number GIF-1TH190

Device Problems Contamination (1120); Fluid/Blood Leak (1250)

Patient Problem Drug Resistant Bacterial Infection (4553)

Event Date 08/23/2022

Event Type  Death  

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 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).

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.

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
• 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: 16161778
• MDR Text Key: 307453501
• Report Number: 9610595-2023-00762
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 10/27/2022
• Initial Date FDA Received: 01/13/2023
• Supplement Dates Manufacturer Received: 05/25/2023; 05/25/2023
• Supplement Dates FDA Received: 05/25/2023; 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2021
• 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): Required Intervention; Death; Other
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 57 KG