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

Model Number TJF-160VR

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

The subject device has not been returned to omsc.But was returned to olympus (b)(4).The subject device was sent to a third party laboratory for additional microbiological testing.In the additional test, staphylococcus coagulase negative (1 cfu/100ml) were detected from the subject device.The testing result cleared french guideline.Omsc reviewed the manufacturing history of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, 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 subject device tested positive for aeromonas hydrophila/caviae (>100cfu/scope).The subject device had been manually reprocessed with peracetic acid.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: EVIS EXERA DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7410580
• MDR Text Key: 105393639
• Report Number: 8010047-2018-00597
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-160VR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1