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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not returned to olympus medical systems corp.(omsc) for evaluation.There were no further details provided.If significant additional information is received, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed that during the inspection of the device, it was found that the ultrasonic transducer surface of the device was missing.Other detailed information was not provided.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, but was returned to olympus europa se & co.Kg (oekg).Oekg confirmed that the acoustic lens of the subject device was missing as reported.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.However, there was the possibility that the reported phenomenon was attributed to the stress during use, the external factor and/or the user handling.

• 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: 10796730
• Report Number: 8010047-2020-08590
• Device Sequence Number: 2849480
• Product Code: ODG
• UDI-Device Identifier: 04953170203107
• UDI-Public: 04953170203107
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2020

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-UE160-AL5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1