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	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the generator displayed an e433 error message during maintenance.During the initial evaluation of the device it was observed, the high voltage power supply board had failed.There were no reports of patient involvement.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
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 and additional information.Updated: d9, h11.Corrected: h3, h6.The investigation is still ongoing.A supplemental report will be submitted when the investigation has been completed or when new and significant information becomes available.Olympus will continue to monitor the field performance of 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: 50778961
• Report Number: 3003724334-2026-00485
• Device Sequence Number: 21503528
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2019
• 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