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

Model Number	USG-410
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 after using the ultrasonic generator for a therapeutic gynecological laparoscopy the patient had a burn scar on her neck.It was believed that something metallic had come into contact with the neck.The patient was currently being treated at the dermatology department of the facility.The patient's hospitalization was not prolonged due to the incident.There was no further impact reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's (lm) investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The subject device was not returned to olympus for evaluation.Based on the results of the investigation, the root cause of the reported event could not be determined.Olympus will continue to monitor field performance for 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: 20035056
• Report Number: 3002808148-2024-07951
• Device Sequence Number: 6573937
• Product Code: LFL
• UDI-Device Identifier: 04953170406881
• UDI-Public: 04953170406881
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 07/26/2024
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2023
• 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: ESG-410 ELECTROSURGICAL GENERATOR (SN (B)(6).; PS-0537CJDA POWERSEAL.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female