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

Model Number	UM-G20-29R
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter establishment name: (b)(6) hospital.During inspection and testing, ultrasonic medium was leaking from the insertion tube.A review of the device history record found no deviations that could have caused or contributed to ultrasonic medium leaking.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely ultrasound medium was leaking from a hole on the distal end sheath.However, a definitive root cause of the reported issue could not be identified.Based on the results of the legal manufacturer's investigation, it is likely air bubbles entered from the perforated part of the tip sheath and hung on the ultrasonic probe.However, a definitive root cause of the reported issue could not be identified.Olympus will continue to monitor field performance for this device.The reported issue (air bubbles) was not confirmed during testing.Testing did find a hole in the insertion tube due to physical stress.Per the legal manufacturer, these device defects have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.
Event or Problem Description
The customer reported that, during preparation of the subject device for use, many air bubbles were generated at the tip of the probe and the image could not be seen due to the air bubbles.The user tried removing the air bubbles as described in the instruction manual but they did not disappear.The procedure was changed to one that did not require a probe and was completed with no impact on the patient.The subject device was sent to an olympus service center for evaluation.During inspection and testing, ultrasonic medium was leaking from the insertion tube.This report is being submitted for the malfunction found during evaluation (leak).

• 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: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16185509
• Report Number: 3002808148-2023-00490
• Device Sequence Number: 14060697
• Product Code: ITX
• UDI-Device Identifier: 04953170368578
• UDI-Public: 04953170368578
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

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: Health Professional
• Device Model Number: UM-G20-29R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• 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: 10/20/2022
• Initial Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2022
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown