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

Model Number	GIF-2TH180
Medical Device Problem Code	Inability to Irrigate (1337)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation.The device was visually inspected and found dents, scratches, broken strands and broken forcep tips.The distal tip and the body control unit is re-assembled.A new bending rubber is installed at the distal tip.A suction capacity test is performed to assure that the endoscope meets original specifications.The endoscope is leak tested to ensure that it is watertight.
Event or Problem Description
It was reported to olympus that there was a service portal channel malfunction and there was a biopsy valve needle stuck in red channel biopsy.It was reported that the reported event occurred during reprocessing and not during a procedure immediately prior to reprocessing.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's investigation and device history record (dhr) review.Updates to section h6.The dhr was reviewed and it was verified that the product was manufactured in accordance with specifications.The legal manufacturer analyzed a photo of the suspect object and verified that the foreign object is not part of the scope and is likely the tip of an endotherapy accessory.The legal manufacturer attributes the likely cause of the reported event to user handling during the procedure.

• 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: 10121747
• Report Number: 8010047-2020-03122
• Device Sequence Number: 16729761
• Product Code: FDS
• UDI-Device Identifier: 04953170275463
• UDI-Public: 04953170275463
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051645
• 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): 07/09/2020

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-2TH180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/05/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1