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

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  Injury  

Event Description

Olympus received a user facility mw reporting five patients experiencing an infection with the microorganism new delhi metalo-beta-lactamase 1 (ndm) producing escherichia coli (e.Coli) following a procedure using an evis exera ii duodenovideoscope.The facility had been notified by the state board of health that one of their inpatients matched the same strain as another patient tested at different facility in (b)(6) 2021.The hospital team initiated an investigation of this report and identified three additional patients with the same organism (ndm producing e.Coli).One of the commonalities discovered was that all five patients had an endoscopic retrograde cholangiopancreatography (ercp).One ercp scope appeared to be common; the scope has been sequestered.Additional details regarding the patients and reported events have been requested.At this time, no additional information has been provided.Case with patient identifier (b)(6) reports patient 1/5.Case with patient identifier (b)(6) reports patient 2/5.Case with patient identifier (b)(6) reports patient 3/5.Case with patient identifier (b)(6) reports patient 4/5.Case with patient identifier (b)(6) reports patient 5/5.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 12980531
• MDR Text Key: 282092669
• Report Number: 2951238-2021-00454
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2021,12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Distributor Facility Aware Date: 11/15/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other