MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. ULTRASONIC GENERATOR

Model Number	USG-400
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laparoscopic hysterectomy using an ultrasonic generator, a u512 error occurred.The customer allegedly tried 2 different transducers with the same result.After asked to separate the electrosurgical generator from the ultrasonic generator and check the linking screws, the screws were tightened, the unit was reassembled, and the error was no longer present.This resulted in a procedural delay of 35 minutes while the patient remained under general anesthesia.It was reported that the patient remained stable, however the laparoscopic hysterectomy was changed to an open hysterectomy due to patient adhesions and surgeon concern that the device would stop working.
Event or Problem Description
This supplemental report is being submitted to provide correction to b2.B2 should have had required intervention checked instead of other serious.

• Brand Name: ULTRASONIC GENERATOR
• Common Device Name: ULTRASONIC GENERATOR
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 21945136
• Report Number: 2429304-2025-00139
• Device Sequence Number: 15733843
• Product Code: LFL
• UDI-Device Identifier: 04953170386817
• UDI-Public: 04953170386817
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2025
• Report Date (Section F): 05/16/2025

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-400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/16/2025
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2025
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ELECTROSURGICAL GENERATOR ESG-400
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 05/16/2025