MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GASTROVIDEOSCOPE

Model Number	GF-UC140P-AL5
Medical Device Problem Codes	Poor Quality Image (1408); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due diligence was executed for this event.Event date is not known.Supplemental report(s) will be filed as any information becomes available.The device has been returned and a device evaluation completed for it.Manufacture date of the device is not known.Upon inspection and testing, it was observed that there was peeling on the light guide lens cement.The evis image had many elements broken and cv noise.User complaint of bad ultrasound image was confirmed.Incidental observations were play of the control knobs.Dunk test was passed by the device and there no fluid observed anywhere.There were some minor scratches and the back cover of the scope connector was loose.
Event or Problem Description
As reported for this event, during an unknown procedure there was bad ultrasound image.There is no reported adverse impact or harm to the patient.
Additional Manufacturer Narrative
There is more information on the device evaluation.This supplemental report is being submitted to provide this information.Please see the updates in sections: g4, g7, h2, h4, and h10.The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing.There was a crack in the distal end cover and peeling of the light guide cement which led to the dirt penetrating inside the lens.Root cause for this issue could not be conclusively determined, but the following factors, occurring from user handling, may have led to the cause: excessive impact or the like was applied to the distal end, resulting in a gap in the tip adhesion, from which dirt penetrated the inside of the lens, leading to the occurrence of a phenomenon.Though it was within the service life of the device, this part was deteriorated by the effect of the use environment, etc., and the gap was generated, and the dirt entered from the saw inside the lens, and the phenomenon was generated.

• Brand Name: ULTRASONIC GASTROVIDEOSCOPE
• Common Device Name: ULTRASONIC GASTROVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10646282
• Report Number: 8010047-2020-07344
• Device Sequence Number: 4284199
• Product Code: ODG
• UDI-Device Identifier: 04953170062803
• UDI-Public: 04953170062803
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K011314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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: No Information
• Device Model Number: GF-UC140P-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1