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

Model Number	GF-UCT180
Medical Device Problem Codes	Image Display Error/Artifact (1304); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user report was confirmed.The error code was presented as a result of foreign matter being stuck on the lens.Once cleaned, the error message went away.If additional information becomes available following device evaluation, a supplemental report will be filed.
Event or Problem Description
It was reported, the evis exera ii ultrasound gastrovideoscope experienced an e311 error during use.There was no patient harm or consequence reported as a result of this event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the manufacturer¿s investigation.A review of the device history record (dhr), a review of the instructions for use (ifu), as well as a historical trending analysis were conducted during this investigation.The review of the dhr did not find any abnormalities or anomalies identified during production.The device met all specifications upon release.The ifu contains the following statements: ¿inspect the external surface of the entire insertion section including the bending section and the distal end for dents, bulges, swelling, scratches, holes, sagging, transformation, bends, adhesion of foreign bodies, missing parts, protruding objects, or other irregularities.¿ a definitive root cause could not be identified.However, based on the results of the investigation, it is believed that external forces applied through daily use or possible reprocessing caused the adhesive to peel/crack.Olympus will continue to monitor the field performance of this device.

• 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: 11864135
• Report Number: 8010047-2021-06611
• Device Sequence Number: 19936894
• Product Code: ODG
• UDI-Device Identifier: 04953170355479
• UDI-Public: 04953170355479
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K093395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2021

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: GF-UCT180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 06/18/2021
• Initial Report FDA Received Date: 05/21/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1