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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Dent in Material (2526)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation found damage/sharp indentations on the probe unit.The image has a glare due to missing glue around the objective lens at the distal end.The ultrasound image has 3 broken elements.Additionally, the light cord has peeling and scratching.The ultrasound cord is dented/buckled.The scope was repaired to standard specifications and returned to asset stock.The investigation is ongoing; therefore, the root cause of the reported malfunction cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.The asset was serviced/inspected on (b)(6) 2020; no problems were noted.This mdr is being submitted retrospectively as part of a remediation effort related to recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required mdr reporting.
Event or Problem Description
During a standard service inspection of a customer returned asset, the ultrasonic gastro-videoscope was found to have a damage/sharp indentations on the probe unit.There was no report of any problems associated with the device and there was no patient injury or harm reported to olympus.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the legal manufacturer's investigation, the device was manufactured more than 12 years ago.As a result, it is likely the peeling is caused by aging deterioration over time.In addition, it is likely that the phenomena occurred due to external force such as strong rubbing on the part in normal use, including reprocessing.The following is described within the instruction manual: "inspect the external surface of the entire insertion tube including the bending section and the distal end for dents, bulges, swelling, scratching, sagging, deformation, excessive bending, protruding objects or other irregularities".

• 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: 11287006
• Report Number: 8010047-2021-02291
• Device Sequence Number: 11723256
• Product Code: ODG
• UDI-Device Identifier: 04953170203107
• UDI-Public: 04953170203107
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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: Other
• Device Model Number: GF-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/03/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1