MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC BIPOLAR GENERATOR; ULTRASONIC GENERATOR

Model Number	USG-410
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is related to the following patient identifiers: (b)(6).The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that during an unknown procedure, the generator had various error codes during use (u504, u508, u510, u511 & u601).The device was used in combination with a thunderbeat where the active branch broke and fell off into the patient's abdomen.It was also reported that the transducer cables were new.Additional information has been requested but nothing received at this time.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following field: h6.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, and although device was not returned, event was confirmed.Malfunction most likely occurred due to circuit failure since handle and transducer were loose.However, a root cause could not be determined.Olympus will continue to monitor the field performance of this device.

• Brand Name: ULTRASONIC BIPOLAR GENERATOR
• Common Device Name: ULTRASONIC GENERATOR
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20658134
• Report Number: 3002808148-2024-10929
• Device Sequence Number: 12887285
• Product Code: LFL
• UDI-Device Identifier: 04953170406881
• UDI-Public: 04953170406881
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K211838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2024

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: USG-410
• Was Device Available for Evaluation?: No
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 11/11/2024
• Supplement Report FDA Received Date: 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TB-0535FCSLOT: PW309411; UNKNOWN TRANSDUCER CABLE
• Patient Sex: Unknown