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

Model Number	UM-G20-29R-3
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse at the user facility reported that the ultrasound images were not clearly output during an unspecified procedure.The procedure was completed using the same device.There was no patient health hazard reported due to the event.The subject device was returned to an olympus service center for evaluation.Upon inspection and testing, service found there were air bubbles in the ultrasonic medium and there was an oily wet feeling on the surface, indicating that there was a possibility that the ultrasonic liquid was leaking.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.
Additional Manufacturer Narrative
Upon further evaluation of the device, service confirmed the customer¿s reported image output issue.The investigation is ongoing; therefore, a root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the customer's complaint was confirmed.Additionally, the repair center found a leakage in the ultrasonic medium and there was a hole in the top sheath.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it¿s likely the ultrasonic image was not depicted normally because air bubbles were mixed in from the perforated portion of the tip sheath and the ultrasonic medium leaks out and decreases from the perforated portion of the tip sheath.The root cause of this event was unable to be identified.Additionally, it¿s likely the ultrasonic medium leaked because a hole was generated in the tip sheath due to external force applied to the device.The root cause of the external force was unable to be duplicated.The following is included in the instructions for use: ¿chapter 3 drawing from the usage endoscope: when pulling the ultrasonic probe out of the endoscope, be sure to set the freeze switch of the observation device to on (freeze state).Pulling the ultrasonic probe while it is driven may damage the ultrasonic probe.¿ olympus will continue to monitor field performance for this device.

• 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 Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15311771
• Report Number: 3002808148-2022-01465
• Device Sequence Number: 6331139
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2022

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-G20-29R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• 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: 07/31/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2022
• 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