MAUDE Adverse Event Report: RICHARD WOLF GMBH POWER CONTROL; MOTOR CONTROL UNIT 2303

Model Number	2303011
Medical Device Problem Code	Failure to Power Up (1476)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, richard wolf gmbh consider this case to be a reportable serious injury.
Event or Problem Description
It was reported that during a holep (holmium laser enucleation of the prostate) procedure, the motor control unit failed.A visual message in german language displays on the screen.Translation: "'caution! "power control" device error!".Also, advising user to contact an authorized service technician.Anytime it is turned on it will sound the alarm with the visual message display.The reported "power control error" issue caused a delay of approximately two-hour during the surgery and placed the patient at risk due to prolonged anesthesia.The issue occurred at the end of the procedure and did not result in any injuries to the patient or other personnel.

• Brand Name: POWER CONTROL
• Common Device Name: MOTOR CONTROL UNIT 2303
• 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: 25477786
• Report Number: 9611102-2026-00028
• Device Sequence Number: 9164821
• Product Code: GEY
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K041610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2026

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: 2303011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2025
• 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: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART ID: 8564.021 - MOTOR HANDPIECE MAX. 6000RPM.; PART ID: 8564.851 - CONNECTION CABLE WL 3M.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown