MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA DUODENOVIDEOSCOPE; DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number	TJF-Q180V
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/27/2021
Type of Reportable Event	Death
Event or Problem Description
State of (b)(6) notified hfh team of an ndm (new delhi metallo-beta-lactamase 1) producing e.Coli strain in one of our inpatients that matched the strain of another patient tested at different facility in july.In investigating, the other patient was a previous patient at hfh as well hfh team started investigating the week of 9/27.Worked with the lab to see if this organism was identified in any other patients at hfh.Three other hfh patients identified with ndm producing e.Coli.Chart reviews began to find any commonalities between the five patients.One of the commonalities discovered was that all patients had an endoscopic retrograde cholangiopancreatography (ercp).One ercp scope appeared to be common; scope sequestered; updated state of (b)(6) team; requested that the other three isolates be sequenced by the state.

• Brand Name: EVIS EXERA DUODENOVIDEOSCOPE
• Common Device Name: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave; san jose CA 95131
• MDR Report Key: 12736742
• Report Number: 12736742
• Device Sequence Number: 1509934
• Product Code: FDT
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2021
• Report Date (Section F): 11/01/2021

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?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2021
• 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: Death
• Patient Weight: 106
• Date Report Sent to FDA: 11/01/2021