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	05/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a holep (holmium laser enucleation of the prostate) procedure, the morcellator power unit failed and a visual message displayed on the screen; 'caution! "power control" device error! also, the visual message advising user to contact a service technician.There are no reports of injuries or unacceptable risks; however, the client reports that the "power control error" issue caused a delay of approximately one and a half hours and required an additional medical procedure using a bipolar electrode to remove the tissue instead of the morcellator.
Additional Manufacturer Narrative
Due to the delay and the additional medical intervention, richard wolf gmbh classify this case as a reportable serious injury.

• 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: 25449044
• Report Number: 9611102-2026-00025
• Device Sequence Number: 15830251
• Product Code: GEY
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/09/2026

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: Other
• Device Model Number: 2303011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 06/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/25/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown