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

Model Number	GIF-N180
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent the subject device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the instrument channel, the suction channel, the air/water channel, and the distal end of the subject device.The testing result cleared the german guideline.(b)(4) checked the subject device and found the followings.The adhesive around the light guide lens and objective lens was porous.The distal end cap was dented.The adhesive of the bending section rubber was porous.The air/water cylinder was worn out.The suction cylinder was worn out.Omsc reviewed the manufacture history (dhr) of the device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.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, leifsonia sp (3 cfu) were detected from the sample collected from the subject device.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: 11511669
• Report Number: 8010047-2021-03902
• Device Sequence Number: 14475284
• Product Code: FDS
• UDI-Device Identifier: 04953170202261
• UDI-Public: 04953170202261
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2021

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: No Information
• Device Model Number: GIF-N180
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1