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

Model Number	GIF-XP180N
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.Olympus contacted the user and got the information that candida tropicalis (1cfu/ endoscope) was detected at the sampling by the user.The subject device was returned to olympus (b)(4).(b)(4) sent the device to a third-party laboratory for microbiological testing.As a result of the testing, staphylococcus coagulase negative (1cfu) was detected from the sample collected from the all channels of the device.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.The reprocessing manual of the subject device has already warns following: 1.4 precautions warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them.
Additional Manufacturer Narrative
The subject device in this report 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 or Problem Description
Olympus medical systems corp.(omsc) was informed that as a result of microbiological testing by the user facility, unspecified microbes were detected from the sample collected from the subject device.The user facility did not provide other detailed information such as the number and the type of microbes.Other detailed information such as the reprocessing method was not provided.There was no report of infection associated with this report.

• 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: 11175436
• Report Number: 8010047-2021-01415
• Device Sequence Number: 16731867
• Product Code: FDS
• UDI-Device Identifier: 04953170307515
• UDI-Public: 04953170307515
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2021

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-XP180N
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/14/2021
• Supplement Report FDA Received Date: 03/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1