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

Model Number	JF-140F
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Olympus received a complaint from a user facility stating that there was concern about two patients that developed carbapenem-resistant enterobacteriaceae (cre) following endoscopic retrograde cholangiopancreatography (ercp).Patient 2 had an ercp, the patient was not known to have cre prior to the ercp.On 1/30/2020 patient 2 had an ercp with jf-140f, sn (b)(4).This particular scope was used on 3 additional patients without any evidence of transmission.On (b)(6) 2020, patient 2 had a urine culture which was positive for cre.The scope was double manually cleaned and double high-level disinfected between patients as is their usual process.Patient 2 was an inpatient on the same unit where another patient tested positive for cre and shared caregivers.Both isolates were sent for genomic analysis and have matching chromosomal patterns.The user facility suspects that transmission occurred either via duodenoscope or through shared caregivers.All the 140 series scopes were sent through eto sterilization, per facility protocol, and were not cultured prior.The jf-140f scope has been quarantined at the user facility.No additional information could be provided by the user facility regarding the treatment of the infections in either patient.This report captures patient 2.An endoscopic support specialist (ess) went onsite to assess the user facility's reprocessing practices.During the observation, ess observed the customer not removing scope from water following leak testing.Only the connector is removed.No other deviations were noted.The user facility has new staff members reprocessing the scopes.Additionally, a reprocessing in-service was conducted on a jf-140f with the customer.The in-service included all cleaning, disinfection and sterilization information that is contained in the olympus manual.In-service was also provided to one new staff member and scheduled another staff member for in-service on a different day to ensure all new staff members are trained properly.

• Brand Name: EVIS 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: 10071671
• Report Number: 2951238-2020-00442
• Device Sequence Number: 766605
• Product Code: FDT
• UDI-Device Identifier: 04953170339844
• UDI-Public: 04953170339844
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/19/2020
• Report Date (Section F): 04/22/2020

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: JF-140F
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/22/2020
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2020
• 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