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 device has not been returned to olympus medical systems corp.(omsc).Omsc reviewed the manufacturing history(dhr) 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 or Problem Description
Olympus was informed that as a result of microbiological testing by the user facility, the subject device tested positive for the following bacteria.The instrument channel a: micrococcus sp.(2cfu/20ml).The auxiliary water channel: pseudomonas sp.(5cfu/20ml).The instrument channel b: no microbial growth.The distal end: no microbial growth.The subject device had been disinfected using non-olympus automated endoscope reprocessor (belimed).There was no report of patient infection associated with this report.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the evaluation result of the device.The subject device had not been returned to olympus medical systems corp.But was returned to olympus europa (b)(4).The subject device was sent to a third-party laboratory for additional microbiological testing.In the additional test, the testing indicated no microbial growth for the subject device.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.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 8825483
• Report Number: 8010047-2019-02700
• Device Sequence Number: 2625117
• Product Code: FDS
• UDI-Device Identifier: 04953170275463
• UDI-Public: 04953170275463
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K051645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: No Information
• Device Model Number: GIF-2TH180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 08/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1