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.
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00139.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction to b2.B2 should have had required intervention checked instead of other serious.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device was not returned to olympus for investigation.However, technical assistance center (tac) provided remote troubleshooting and instructed the customer to separate the esg from usg and check the linking screws.Customer tightened the screws and reassembled the unit.The error is no longer present and the procedure continued.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.The customer report was confirmed with tac, the device needed the linking screws tightened.The most probable cause of the customer¿s report cause not established: the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.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
No additional information received from customer.

• 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
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21945176
• Report Number: 9614641-2025-00643
• Device Sequence Number: 21096348
• Product Code: LFL
• UDI-Device Identifier: 04953170386817
• UDI-Public: 04953170386817
• Combination Product (Y/N): N
• Initial Reporter State: UT
• PMA/510(K) Number: K172691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/14/2025

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 05/16/2025; 10/15/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/16/2025; 11/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ELECTROSURGICAL GENERATOR ESG-400.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female