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

Model Number	2303011
Medical Device Problem Code	Complete Loss of Power (4015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although no injuries or unacceptable risks to the patient were reported, richard wolf gmbh (rwgmbh) consider this case a "reportable malfunction" due to a similar issue being reported as a "serious injury" in the last two years.
Event or Problem Description
It was reported that during morcellation, (holep) procedure, the blades were not rotating in the handle.Upon changing to a different machine, the blade rotated, and the handle worked.There was no reported delay and the scheduled procedure was completed.There was no report of any patient harm.
Additional Manufacturer Narrative
The motor control unit 2303, part id 2303.011, sn (b)(6) was investigated, and no defects were found during the inspection.The unit was checked, and an endurance test was even performed.The motor functioned without any problems.During the inspection, the motor socket was found to be worn out and should be replaced.However, the device is eight years old.This is due to normal wear and tears.Since the reported defect could not be found, the root cause of the problem cannot be determined.The motor control unit 2303 type 2303.011 with serial number (b)(6) was manufactured on march 30, 2017.The production order contains six units, and no abnormalities were detected during the manufacturing process.Since the first delivery to (b)(4) on april 24, 2017, there have been no further complaints regarding this serial number.During the last two years, richard wolf gmbh has received a total of ten repair orders with various concerns.The subject issue of functional malfunction/loss of function due to an unusable product is present in the risk management file e5-1: propulsion systems, control units with accessories, cl.Ila, v00.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.The risk profile remains unchanged.

• 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: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 22795259
• Report Number: 9611102-2025-00041
• Device Sequence Number: 8264543
• Product Code: GEY
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2025

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
• Device Model Number: 2303011
• Device Catalogue Number: 2303.011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 10/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2017
• 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
• Patient Sex: Unknown