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

Model Number	UM-2R
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after cleaning and disinfecting the ultrasonic probe, a black liquid came out from the black part that connects to the drive unit after it was removed from the cleaning machine.The issue was found during reprocessing and there were no reports of patient involvement.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction: this supplemental correction for section d4, updated from unknown to1371570.This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.A device history review revealed no issues that could have caused or contributed to the reported issue.The device was returned for evaluation and the customer's allegation was confirmed.In additional, the device evaluation found liquid leaking from the connector connection and twisting/tearing of the connector connection.Based on the results of the investigation, it is likely that the following led to the malfunction: the most probable cause of the complaint is component failure should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that after cleaning and disinfecting the ultrasonic probe, a black liquid came out from the black part that connects to the drive unit after it was removed from the cleaning machine.The issue was found during reprocessing and there were no reports of patient involvement.
Additional Manufacturer Narrative
Correction: (d4) - blank to (b)(4).Additional: (d9) - blank to 4/24/2024.
Event or Problem Description
It was reported that after cleaning and disinfecting the ultrasonic probe, a black liquid came out from the black part that connects to the drive unit after it was removed from the cleaning machine.The issue was found during reprocessing and there were no reports of patient involvement.

• 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: 19330439
• Report Number: 3002808148-2024-33094
• Device Sequence Number: 11538634
• Product Code: ITX
• UDI-Device Identifier: 04953170368554
• UDI-Public: 04953170368554
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/11/2024

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-2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/16/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 05/16/2024; 06/10/2024
• Initial Report FDA Received Date: 05/16/2024
• Supplement Report FDA Received Date: 06/06/2024; 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/05/2013
• 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