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

Model Number	GIF-2TH180
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not been returned to olympus medical systems corp.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause could not be determined at present.If significant additional information is received, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that the subject device tested positive for following bacteria during a surveillance culturing test at the facility on (b)(6) 2018.Biopsy channel 1: staphylococcus aureus (990cfu/ml), biopsy channel 2: staphylococcus aureus (1cfu/ml), auxiliary channel: staphylococcus aureus (990cfu/ml).It was also reported that the subject device tested positive for following bacteria (18cfu/endoscope) during additional microbiological culturing test at the facility on (b)(6) 2018.Biopsy channel 1 :coagulase negative staphylococcus aureus (1cfu/ml), air/water channel: staphylococcus aureus (990cfu/ml), auxiliary channel: micrococcus (1cfu/ml).Other detailed information such as reprocessing method was not provided from the facility but there was no report of patient infection associated with the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.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, the air/water channel tested positive for unspecified bacteria (1cfu/channel) but the testing result cleared (b)(4) guideline.The test result indicated no microbial growth for the instrument channels (1 and 2).The exact cause could not be determined.

• Brand Name: EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
• Common Device Name: GASTROINTESTINAL VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7576653
• Report Number: 8010047-2018-01015
• Device Sequence Number: 1922956
• Product Code: FDS
• UDI-Device Identifier: 04953170275463
• UDI-Public: 04953170275463
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2019

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
• Operator of Device: Health Professional
• Device Model Number: GIF-2TH180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/11/2018
• Supplement Date Received by Manufacturer: 06/06/2018; 02/13/2019
• Initial Report FDA Received Date: 06/06/2018
• Supplement Report FDA Received Date: 07/02/2018; 03/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1