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

Model Number	GF-UE160-AL5
Medical Device Problem Codes	Leak/Splash (1354); Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Inspection of the device determined that the probe unit pink rubber was observed with deep cut.The um (ultrasound image) was found with 5 broken elements and 7 plus broken strands were observed on the bending section.The control knob was determined with low tension and leak on the um monitor connector was observed.Device was placed for repair.The reported issue was confirmed.Probable cause could be attributed to user handling and or maintenance issue.If additional information becomes available this report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported that the device was found with chipped lens and leak on the tip of the scope was observed.The issue occurred during reprocessing.There was no patient involvement on this event.No user injury reported.
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.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.Based on the results of the investigation, it is presumed that the reported phenomenon occurred due to device age deterioration and or external force such as strong rubbing on the device in normal use including reprocess.Olympus will continue to monitor complaints for this device.

• 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: 11204832
• Report Number: 8010047-2021-01656
• Device Sequence Number: 2231891
• Product Code: ODG
• UDI-Device Identifier: 04953170310546
• UDI-Public: 04953170310546
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 02/18/2021

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-UE160-AL5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1