MAUDE Adverse Event Report: Richard Wolf GmbH; HF SURGERY GENERATOR 400KHZ

Model Number	2260003
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2026
Type of Reportable Event	Serious Injury

• Common Device Name: HF SURGERY GENERATOR 400KHZ
• Manufacturer (Section D): Richard Wolf GmbH; pforzheimer straße 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): Richard Wolf GmbH; pforzheimer straße 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer straße 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 50952152
• Report Number: 9611102-2026-00068
• Device Sequence Number: 13145226
• Product Code: GEI
• UDI-Device Identifier: 04055207063392
• UDI-Public: 04055207063392
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K230194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Device Model Number: 2260003
• Device Catalogue Number: 2260003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/18/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown