MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR "ESG-410"; WA91307W

Model Number	WA91307W
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the electrosurgical generator had untimely ignitions that occurred during sedation for a therapeutic bladder resection, leading to the procedure being cancelled and needing to be rescheduled.In addition, this increased the length of the hospital stay, and the patient was currently awaiting conditions for rescheduling.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the final investigation.Based on the results of the investigation, the subject device was not returned for evaluation and the root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.Updated fields: d9, h3 and h6.The device was returned to olympus for inspection and the reported failure was not confirmed.A definitive root cause could not be determined.The most probable cause was not established; the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.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 was received from the customer.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-410"
• Common Device Name: WA91307W
• 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: 22330628
• Report Number: 3003724334-2025-00276
• Device Sequence Number: 9436231
• Product Code: GEI
• UDI-Device Identifier: 04042761086332
• UDI-Public: 04042761086332
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K203277
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2025

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: WA91307W
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/08/2025; 11/05/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/11/2025; 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown