MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

Model Number	UM-G20-29R-3
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation where service confirmed the customer's complaint.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Additionally, there is a hole in the sheath at the tip, and there is leakage of the ultrasonic medium.Based on the results of the investigation, it is likely that the ultrasound image cannot be depicted normally because the ultrasound medium is reduced, and the ultrasound cannot be transmitted normally.Regarding the hole in the sheath, it is likely that some stress was applied to the sheath at the tip, and the sheath at the tip was damaged, leading to the puncture.A definitive root cause cannot be identified.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
The customer reported to olympus that the ultrasound images were not clear.The reported problem was found during preparation for an unspecified procedure.There was no harm or user injury reported due to the event.The device was returned to service where evaluation found the device image was not visible and there was a hole in the sheath at the tip, causing leakage.This report is being submitted for the malfunctions found at evaluation.

• Brand Name: ULTRASONIC PROBE
• Common Device Name: ULTRASONIC PROBE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: lydia sakakeeny ; 800 west park drive; westborough, MA 01581 ; 6177976458
• MDR Report Key: 17091520
• Report Number: 3002808148-2023-05754
• Device Sequence Number: 6070227
• Product Code: ITX
• UDI-Device Identifier: 04953170078668
• UDI-Public: 04953170078668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

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: UM-G20-29R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown