MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE

Model Number	GIF-1TH190
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	10/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported after being notified by the state board of health, a cluster of six gastroenterology patients have been diagnosed with the same strain of carbapenemase-producing pseudomonas aeruginosa (cppa) during a six-month period.All six patients were found to have undergone procedures using the same evis exera iii gastrointestinal videoscope.Patient 1 of 6 is reported in case with patient identifier (b)(6).Patient 2 of 6 is reported in case with patient identifier (b)(6).Patient 3 of 6 is reported in case with patient identifier (b)(6).Patient 4 of 6 is reported in case with patient identifier (b)(6).Patient 5 of 6 is reported in case with patient identifier (b)(6).Patient 6 of 6 is reported in case with patient identifier (b)(6).In this patient case: eight days after an endoscopic ultrasound (eus)/esophagogastroduodenoscopy (egd) with stent placement using an evis exera iii gastrointestinal videoscope, the patient had blood culture results showing: pseudomonas aeruginosa, carbapenem resistant (carbapenemase producer).The patient required unspecified treatment due to the infection.The indication for the procedure was malignant tumor of the head of pancreas, gastric outlet obstruction, duodenal stenting, and staging of malignant ascites.The patients history was significant for: metastatic pancreatic adenocarcinoma, gastric outlet obstruction, diabetes mellitus (dm), and admission from hospice care for vancomycin resistant enterococcus (vre) bacteremia.The patients current condition is reported as deceased.The patients cause of death is not known to be associated with the device at this time.Cause of death has been requested, but not provided at the time of this report.The customer verified there was no malfunction of the olympus scope during the procedure.The customer reports after becoming aware of these events, the scope was immediately quarantined.The suspect scope was cultured, and all cultures were negative for pseudomonas aeruginosa.The customer also reports the suspect scope was carefully examined with no abnormalities noted.No breaches were found from standard high-level disinfection processes.
Event or Problem Description
Correction to g3 of the initial medwatch.The aware date should be 23-jun-2021.
Event or Problem Description
This supplemental report is being submitted to update section b2.

• Brand Name: EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12180793
• Report Number: 2951238-2021-00364
• Device Sequence Number: 1022176
• Product Code: FDS
• UDI-Device Identifier: 04953170343360
• UDI-Public: 04953170343360
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2022
• Report Date (Section F): 06/23/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: GIF-1TH190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Supplement Date Received by Manufacturer: 07/15/2021; 07/15/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 12/07/2022; 07/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDIVATOR AER.; MEDIVATOR AER
• Outcome Attributed to Adverse Event: Required Intervention; Other; Death
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 68 KG