MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR ESG-410; WA91327U

Model Number	WA91327U
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported when using the generator with a thunderbeat handpiece, there was no activation.The issue occurred during a sleeve gastrectomy procedure while the patient was sedated.The user connected a bovie pencil and bovie pad and had the same issue.The generator gave an e0728 system error and an e1809 neutral electrode disconnected error.The user tried another pad and electrode, but the device continued to error.The procedure was completed with manual over sewing and was prolonged greater than 30 minutes.There were no further reports of patient harm.

• Brand Name: ELECTROSURGICAL GENERATOR ESG-410
• Common Device Name: WA91327U
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH BERLIN FACILITY; rheinstrasse 8; teltow, brandenburg 14513 ; GM 14513
• MDR Report Key: 21359460
• Report Number: 2429304-2025-00075
• Device Sequence Number: 8437480
• Product Code: GEI
• UDI-Device Identifier: 04042761087698
• UDI-Public: 04042761087698
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025
• Report Date (Section F): 02/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: WA91327U
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/17/2025
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOVIE PAD; BOVIE PENCIL; ELECTRODE; THUNDERBEAT HANDPIECE
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/11/2025