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

Model Number TJF-Q180V

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of routine microbiological testing by the user facility, the sample collected from the subject device tested positive for enterobacter cloacae (> 100 cfu).Other detailed information such as the reprocessing method was not provided.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) obtained an additional information from the facility that no microbes were detected from the sample collected from the subject device in (b)(6) 2020, before the subject device was tested positive in (b)(6) 2020.The subject device was not returned to either olympus france (ofr) or omsc, but was sent to a third party for repair.Ofr obtained a maintenance report by the third party, and blockage of the aspiration channel was confirmed.According to the service record in ofr, the subject device was last serviced in (b)(6) 2017 by ofr regional repair center.Ofr dispatched a hygiene trainer to the facility in order to observe the device handling practice of the user.Ofr raised some recommendations to the user facility regarding device storage and reprocessing.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.

• 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: 10964729
• MDR Text Key: 226919827
• Report Number: 8010047-2020-10018
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/08/2020
• Supplement Dates Manufacturer Received: 12/07/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1