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

Model Number	UM-S20-20R
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection and testing of the device, the lack of ultrasound medium was possibly due to a leak from the device.In addition, service also found abnormal ultrasonic images.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time; however, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The subject device was returned to olympus from a user facility with no alleged complaint.During receipt inspection, it was found that the waterproof cap was missing and could not be washed.Upon further inspection and testing of the device, it was observed that there was a lack of ultrasound medium within the device.This report is being submitted for the malfunction found during evaluation (lack of ultrasound medium).There was no patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 11 years since the subject device was manufactured.Based on the results of the investigation, the ultrasonic medium leaked and the ultrasonic image could not be displayed because of the occurrence of a perforation in the sheath.The specific root cause could not be determined at this time.The following information is stated in the instructions for use: "3.2 inspection 2.Carefully run your fingertips over the entire length of the insertion tube.Inspect for any protrusions, bends, leakage of ultrasonic propagation fluid medium or other irregularities." olympus will continue to monitor field performance for this device.

• Brand Name: ULTRASONIC PROBE
• Common Device Name: ULTRASONIC PROBE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13759507
• Report Number: 8010047-2022-04379
• Device Sequence Number: 5749855
• Product Code: ITX
• UDI-Device Identifier: 04953170368592
• UDI-Public: 04953170368592
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2022

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: UM-S20-20R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2011
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown