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

Model Number	2303011
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information received, the suction pump, part 2208011, sn# (b)(6), stopped working during a holep procedure.The reported problem caused the procedure to be cancelled after a delay of approx.2 hours.
Additional Manufacturer Narrative
The suction pump 2208011, sn: (b)(6) was investigated and no defects were found during the inspection.The pump functioned without any problems.Afterwards, the suction pump was investigated together with the motor control unit 2303, part id 2303.011, sn(b)(6) (concomitant device).It was determined that the motor handle m4 does not rotate and is not recognized.The fault is with the motor board 64352047, which must be replaced.The probable root cause is sporadic failure of the motor board 64352047.The motor control unit 2303 sn: (b)(6) was manufactured on 02/oct/2024.No issue was identified during production.No further complaints were received from the reported production order.In general, the user is advised in the associated instructions for use ga-a202-us / en / 2020-10 v2.0 under chapter 4 that a visual and functional inspection must be carried out before and after each use.Possible damage of the above kind can be easily detected by hospital staff if these instructions are followed.In our risk analysis e5-1, v00, control units with accessories, manufacturing-related, handling-related and design-related hazards with regard to functional impairment, as well as risks from a non-deployable product with the corresponding extent of damage and the assumed probability of occurrence, were considered and assessed as an acceptable risk.No systematic defects can be derived from the inspection of the control unit from a manufacturing or design point of view.The rate of complaints in comparable cases is very low.

• 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: 21600589
• Report Number: 9611102-2025-00011
• Device Sequence Number: 9216080
• Product Code: GEY
• UDI-Device Identifier: 04055207056653
• UDI-Public: 04055207056653
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2303.011, MOTOR CONTROL UNIT 2303SN# (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown