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

Model Number	GF-UE160-AL5
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced scope was returned to the service center for evaluation.The evaluation confirmed the scope was leaking due to a cut/hole on the ultrasound cord.Additionally, the pink colored probe unit had deep tear; exposing the probe's core.There was a shadow on the echo line of the ultrasound image.Further diagnostics found fluid invasion and heavy corrosion inside of the scope connector.The scope was last repaired (for leaking) on may 7, 2015.The investigation is ongoing.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
The service center was informed by the user facility that the ultrasonic gastro-videoscope had a leak.No patient involvement was reported.
Additional Manufacturer Narrative
This supplemental report was submitted to provide additional information to mdr# 8010047-2020-08198.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The peeling of the acoustic lens has been confirmed from the image, and it is considered that the external force was applied to the distal end part, because the loss of the sound line was also confirmed.It is speculated that the external force applied to the applied region resulted in the generation of this phenomenon.Olympus will continue to monitor the field performance of this device.To mitigate the risk of peeling of the acoustic lens, the instructions for use provides the following information: important information - please read before use - do not apply shock to the distal end of the insertion tube,particularly the ultrasonic transducer and the objective lens surface at the distal end.This could cause abnormalities in the visual and/or ultrasonic images.".

• 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: 10743742
• Report Number: 8010047-2020-08198
• Device Sequence Number: 11514842
• Product Code: ODG
• UDI-Device Identifier: 04953170310546
• UDI-Public: 04953170310546
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 10/27/2020
• 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