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

Model Number	WA91307W
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Self-Activation or Keying (1557); Communication or Transmission Problem (2896); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
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 that the generator displayed an insufficient conductivity alarm, and no instrument connected (when connected to the cable), and spontaneous activation of cut output (resulting in inadvertent cutting of tissue); no activation of the footswitch.The alarms stopped when hf cable was reconnected to universal 1 socket, and the cut tissue was resolved by the surgeon removing/resecting it.The issue was observed during a therapeutic trans-urethral resection of bladder tumour procedure.The procedure was completed with the same device.There were no reports of patient injury/harm.
Additional Manufacturer Narrative
The device was not returned to olympus for inspection and the reported failure was not confirmed.Based on the results of the investigation, a root cause could not be identified.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
There is no new information provided by 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: 22914773
• Report Number: 3003724334-2025-00411
• Device Sequence Number: 9055366
• Product Code: GEI
• UDI-Device Identifier: 04042761086332
• UDI-Public: 04042761086332
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K203277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA91307W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• 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: CYSTOSCOPE (MODEL/SERIAL NUMBER UNKNOWN); LOOP ELECTRODE (MODEL/LOT NUMBER UNKNOWN); RESECTOSCOPE (MODEL/SERIAL NUMBER UNKNOWN); WA00014A HF CABLE SERIAL NUMBER (B)(6); WA91301W FOOT SWITCH (SERIAL NUMBER UNKNOWN); WORKING ELEMENT ((MODEL/SERIAL NUMBER UNKNOWN)
• Patient Sex: Unknown