MAUDE Adverse Event Report: Olympus Winter & Ibe GmbH Berlin Facility Olympus ESG-100, 100...120 V~,; Electrosurgical system generator

Model Number	WB991046
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction

• Brand Name: Olympus ESG-100, 100...120 V~,
• Common Device Name: Electrosurgical system generator
• 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: 50847859
• Report Number: 3003724334-2026-00497
• Device Sequence Number: 13150001
• Product Code: GEI
• UDI-Device Identifier: 04042768910463
• UDI-Public: 04042768910463
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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: WB991046
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/21/2026
• 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
• Patient Sex: Unknown