MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE

Model Number	GF-UCT180
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.Evaluation determined that their was unidentified object stuck under the elevator raiser assembly of the device.It was determined to be a dried debris and was removed.In addition, the rubber part of the device was replaced and the angulation level of the scope was adjusted.Fog testing was performed and the device passed the testing.As stated on the ifu and as a preventive measure, the user manual states : never use the endoscope on a patient if any irregularity is observed.Damage or irregularity in the instrument may compromise patient or user safety and may result in more severe equipment damage.
Event or Problem Description
It was reported that during a set up pre procedure, upon inspection, it was found that there was a foreign material stuck at the lifter level body of the device.There was no patient involvement on this event.To date there was no patient infection or harm reported due to the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the review of the device history records (dhr).The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause could not be determined however, the most probable cause of the issue was due to device maintenance issue and or device handling issue.

• Brand Name: EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE
• Common Device Name: ULTRASOUND GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9941132
• Report Number: 8010047-2020-02067
• Device Sequence Number: 10932369
• Product Code: ODG
• UDI-Device Identifier: 04953170355462
• UDI-Public: 04953170355462
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2020

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: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1