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

Model Number TJF-Q180V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 09/27/2021

Event Type  Death  

Event 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
• Type of Device: DUODENOSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2400 ringwood ave; san jose CA 95131
• MDR Report Key: 12736742
• MDR Text Key: 279621847
• Report Number: 12736742
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/01/2021
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 24820 DA
• Patient Weight: 106