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.

• 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
• MDR Report Key: 22819402
• Report Number: 2429304-2025-00226
• Device Sequence Number: 14887655
• Product Code: GEI
• UDI-Device Identifier: 04042761086349
• UDI-Public: 04042761086349
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/15/2025
• Report Date (Section F): 08/15/2025

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: WA91307C
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/18/2025
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2025
• 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: WA22751S HF-RESECTION ELECTRODE "PLASMAROLLER"; WIRED FOOTSWITCH; WIRELESS FOOTSWITCH
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/15/2025