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.
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2025-00075.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 a correction and the results of the investigation.Updated fields: h2 and h6.Corrections to: b1, b2, and h1.This event was initially conservatively reported as a serious injury; however, there is no evidence the patient suffered any serious injury or adverse effects from the prolonged procedure.Olympus made multiple attempts to receive more information from the customer without success.Thus, correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.The h6 medical device problem reported would not cause or contribute to a death or a serious injury if it were to recur.The customer had contacted olympus technical assistance support (tac) and was advised to return the device for repair as the device failed to function upon initial clinical use.The device was returned and the product analysis was unable to duplicate the user request as the device passed all functional tests, however it did have a damaged top cover that needed replacement.Based on the results of the investigation, the complaint was not confirmed as the device passed all functional tests.The definitive root cause of the reported issue could not be determined.The most probable cause of the complaint is device problem excluded where the investigation findings clearly confirm that there was no problem with the reported problem on the device.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• 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
• 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 ; 5082077661
• MDR Report Key: 21359549
• Report Number: 3003724334-2025-00048
• Device Sequence Number: 12865911
• Product Code: GEI
• UDI-Device Identifier: 04042761087698
• UDI-Public: 04042761087698
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K231777
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/26/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOVIE PAD; BOVIE PENCIL; ELECTRODE; THUNDERBEAT HANDPIECE
• Patient Sex: Unknown