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
The customer reported that when using the universal output of the electrosurgical generator, the message "no instrument connected" appeared on the screen during an unspecified procedure and therefore, switched to a different device.No patient harm was reported.
Additional Manufacturer Narrative
Date of event is unknown.Additional information will be provided if available.The device was returned to olympus for inspection and the customer allegation was confirmed.The customer allegation is related to error message e486 and was caused by a defective motherboard.The high frequency leakage current, failed current and power consumption and failed power output are consequences of the defect motherboard as root cause.Based on the results of the investigation, the most probable cause of the reported issue is traced to the device.However, a definitive root of reported issue could not be identified.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: 50819910
• Report Number: 3003724334-2026-00488
• Device Sequence Number: 10697163
• Product Code: GEI
• UDI-Device Identifier: 04042761076838
• UDI-Public: 04042761076838
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 05/06/2026
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2013
• 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
• Patient Sex: Unknown