MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BERLIN FACILITY ELECTROSURGICAL GENERATOR "ESG-410"; WA91307C

Model Number	WA91307C
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a therapeutic transurethral resection of a bladder tumor (turbt) procedure, the electrosurgical generator had no energy.Both the wired footswitch and wireless footswitch were attempted.The footswitch indicator on the device was indicating the footswitches were passing a signal but there was no energy present.There were no error codes present.The patient was under general anesthesia at that time.The case was subsequently cancelled due to the event.The customer received a replacement electrosurgical generator.The patient was then brought back for a second attempt procedure on (b)(6) 2025 in which they underwent general anesthesia again.The second procedure was completed successfully.There were no reports of patient harm.It was reported that no testing of the device was done before the first procedure attempt.The customer plugged things in as usual and began the case.All appeared normal until the physician was in the patient and the electrosurgical generator would not fire.It did not respond to pedal steps or resets.It did not respond to new loops.All connections were checked and reset without success.Thus, the case was cancelled.
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
No additional information received from customer.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Updated fields: d9, h2, h4, h6, h11.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue 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.

• Brand Name: ELECTROSURGICAL GENERATOR "ESG-410"
• Common Device Name: WA91307C
• 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: 22819404
• Report Number: 3003724334-2025-00380
• Device Sequence Number: 20268440
• Product Code: GEI
• UDI-Device Identifier: 04042761086349
• UDI-Public: 04042761086349
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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: WA91307C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2021
• 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: WA22751S HF-RESECTION ELECTRODE "PLASMAROLLER"; WIRED FOOTSWITCH; WIRELESS FOOTSWITCH
• Patient Sex: Unknown