MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number	TJF-Q180V
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus the evis exera ii duodenovideoscope was a scope of potential infection after being notified by the maine center for disease control (cdc) that they were dealing with a carbapenem-resistant enterobacterial (cre) organism.The scope of concern was cultured by the customer on (b)(6) 2020, (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021.On (b)(6) 2021 the scope was tested after a known cre case.The scope tested negative after each culture on (b)(6) 2020, (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021.The epidemiologist was made aware of a cluster of patients that were infected over 1 year ago with carbapenem-resistant enterobacteriaceae (highly resistant cp-cre organism).A "few patients" tested positive; however, reprocessing department was never informed.The reprocessing department was instructed to pull the device out of service on (b)(6) 2021.The device was cultured on (b)(6) 2021.The culture was done after the device had been disinfected numerous times as the patient infection occurred in (b)(6) 2020.The device culture was negative.The customer further reported that they had three patients who had been examined by this particular scope and were genetically identical e.Cloacae.This complaint is for patient 2, a (b)(6) year old female weighing (b)(6) kilograms with a medical history of pneumonia, hypertension, hypothyroidism, paroxysmal atrial fibrillation, and peptic ulcer disease.The patient was scoped with the subject device for biliary obstruction and cholangioca (b)(6) 2020 and (b)(6) 2020.The patient was later diagnosed with sepsis after her blood was cultured and tested positive for kpc-e.Cloacae on (b)(6) 2021.The patient received iv antibiotics for sepsis and her current status is reported as living.Patient identifier (b)(6) is for patient 1 of 3.Patient identifier (b)(6) is for patient 3 of 3.This complaint is for patient identifier (b)(6) for patient 2 of 3.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12557860
• Report Number: 2951238-2021-00421
• Device Sequence Number: 1167398
• Product Code: FDT
• UDI-Device Identifier: 04953170229503
• UDI-Public: 04953170229503
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/30/2021
• Report Date (Section F): 09/24/2021

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: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2021
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Weight: 85