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)
Date of Event	09/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the generator had an e433 error during an unspecfied procedure.During the initial evaluation of the device it was observed, the generator board had failed.No patient harm was reported.
Additional Manufacturer Narrative
The device was returned to olympus for inspection and the reported failures were¿confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunctions: an electrical related component failure.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: 50900083
• Report Number: 3003724334-2026-00508
• Device Sequence Number: 6001725
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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
• Device Lot Number: B012192
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/08/2024
• 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