MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Berlin Facility HF unit "ESG-400"; Electrosurgical generator ESG-400

Model Number	WB91051W
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the electrosurgical generator esg-400 displayed an e433 error, and the system is restarting automatically.The issue occurred during set up or inspection for use.There were no reports of patient harm.
Additional Manufacturer Narrative
E1 - initial reporter establishment name: (b)(6).E1 - address: (b)(6).The device was returned to olympus for inspection.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: the most likely cause of failure is an electrical defect, such as electronic components damage or deterioration, poor contact at electrical connection points, etc.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: HF unit "ESG-400"
• Common Device Name: Electrosurgical generator ESG-400
• Manufacturer (Section D): Olympus Winter & Ibe GmbH Berlin Facility; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer (Section G): Olympus Winter & Ibe GmbH Berlin Facility; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; +1(508)207-7661
• MDR Report Key: 50876826
• Report Number: 3003724334-2026-00502
• Device Sequence Number: 15759113
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K203682
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: WB91051W
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/08/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown