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

Model Number	GIF-N180
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The device was evaluated and it was determined that there was a leak on the a rubber and the bending section was frayed at the joint.The cause for this damage cannot be conclusively determined.
Event or Problem Description
It was reported that during reprocessing, the device was found to be leaking at the distal tip.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information (h10) and corrected data (h10) regarding the reported event.Additional information/corrected data: upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 10105415
• Report Number: 8010047-2020-03024
• Device Sequence Number: 16365488
• Product Code: FDS
• UDI-Device Identifier: 04953170202261
• UDI-Public: 04953170202261
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K100584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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-N180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1