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	05/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Due to the delay and the additional medical intervention, richard wolf gmbh (manufacturer) classify this case as 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.Once these visual displays the machine is no longer functional.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 delay of the surgery, removing the specimen manually.According to the user, patient was placed under sedation longer than necessary and this resulted in an increased risk of bladder injury for the patient.

• Brand Name: POWER CONTROL
• Common Device Name: MOTOR CONTROL UNIT 2303
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 25449055
• Report Number: 1418479-2026-00005
• Device Sequence Number: 9510544
• Product Code: GEY
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/09/2026
• Report Date (Section F): 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
• Device Model Number: 2303011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2026
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/24/2026
• Device Age: 29 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/09/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PART ID: (B)(6) - FOOTSWITCH 1 PEDAL / LOT11844; PART ID: (B)(6) - CONNECTION CABLE WL 3M; PART ID: (B)(6) - MOTOR HANDPIECE MAX. 6000RPM; PART ID: (B)(6) - SUCTION PUMP / (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/09/2026