MAUDE Adverse Event Report: RICHARD WOLF GMBH POWERSPEED AS1; MOTOR CONTROL UNIT 2305

Model Number	2305001
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The motor control unit 2305, type 2305001, was examined in the specialist department.It was found that the connection cable to the motor boards on the processor card was not plugged in.The device immediately goes into fault mode during the self-test.The cause of this error cannot be determined.The motor control unit 2305, type 2305001, sn # (b)(6), was manufactured on february 29, 2024, with a quantity of (b)(4) units and delivered to the customer on june 12, 2024.A review of the production schedules did not reveal any abnormalities in the manufacturing process.According to the instructions for use ga-a304 / en / us / v1.0 / 2022-09, the user is advised in chapter 5 that the motor control unit and the system must be visually inspected and checked for proper functioning before and after each use.In our risk analysis e5-1, v00, potential hazards triggered by a loss of function were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed as an acceptable risk.Since this error is normally detected during the self-test before use, the risk assessment remains valid in view of the facts described.The inspection of the motor control unit did not reveal any systematic defects from a manufacturing or design perspective.Based on the results described above, this is considered an isolated case that cannot be traced.No further measures are being considered in relation to the test results.
Event or Problem Description
The customer reported the following: during the patient's anesthesia, shortly before the scheduled surgery, an error message appeared when attempting to connect the drill to the shaver system.This resulted in the patient's awakening and the cancellation of the procedure.There were no reported injuries to patient/users or third parties.No information is available about the type of procedure, or the measures taken during the incident.However, as the procedure was aborted, the three subsequent procedures were also cancelled.

• Brand Name: POWERSPEED AS1
• Common Device Name: MOTOR CONTROL UNIT 2305
• 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: 22088908
• Report Number: 9611102-2025-00023
• Device Sequence Number: 20838741
• Product Code: GEY
• UDI-Device Identifier: 04055207056660
• UDI-Public: 04055207056660
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 05/27/2025

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: 2305001
• Device Catalogue Number: 2305001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Initial Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown