MAUDE Adverse Event Report: RICHARD WOLF GMBH POWER STICK M4; MOTOR HANDPIECE MAX. 6000RPM

Model Number	8564021
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The motor handpiece max.6000rpm, type 8564.021, with serial number (b)(6), originates from production order (b)(4).With an order quantity of 20 pieces.A review of the production schedule for this serial number revealed no anomalies or deviations.The item was delivered to the customer on (b)(6) 2019.The motor handle assembly was checked and extensively tested in the specialist department.It was found that the connector pins of the motor handle are heavily corroded, and the valve o-ring is worn.The cause can be traced back to non-compliance with the instructions for preparing the motor handle as described in the operating instructions.In general, the user is advised in the corresponding operating instructions ifu ga-a238, chapter 4, that a visual and functional check must be carried out before and after each use.Due to possible sporadic failures.The user is advised in ga-a238, chapter 1.6, that an equivalent instrument or device replacement should be available for therapeutic applications.In our risk analysis e5-2 rev.07, manufacturing-related, handling-related, and design-related hazards with regard to functional impairment and risks due to a product that cannot be used were considered with the corresponding extent of damage and the assumed probability of occurrence and assessed as an acceptable risk.No comparable cases of this type 8564.021 were registered during the period under review.As the investigation of the current complaint did not reveal any new risks, the risk assessment remains valid, even taking into account the possibility of recurrence.
Event or Problem Description
It was reported that, during the middle of the morcellation process, the generator stopped and triggered the alarm.The user restarted the equipment.However, the alarm continued and failed to stop.The surgery was cancelled and instead a prostate probe was performed.The patient was rescheduled for surgery on (b)(6) 2025 for a prostatic adenoma.There are no reports of health problems and patient is doing well.

• Brand Name: POWER STICK M4
• Common Device Name: MOTOR HANDPIECE MAX. 6000RPM
• 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: heiko seider-biedermann ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 22371510
• Report Number: 9611102-2025-00028
• Device Sequence Number: 14562131
• Product Code: GEY
• UDI-Device Identifier: 04055207017982
• UDI-Public: 04055207017982
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2025

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: 8564021
• Device Catalogue Number: 8564.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2019
• 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