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

Model Number	8564021
Medical Device Problem Code	Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although there are no reports of injuries or risks to the patient or other personnel, richard wolf gmbh consider this case to be a reportable malfunction because there have been reports of similar issues, which were reported as serious injury in the last two years.
Event or Problem Description
It was reported that the handpiece has failed to provide the intended suction during a holmium laser enucleation of the prostate (holep) procedure.There is no report of injury to the patient or other personnel.However, the reported issue caused a 20 - 30 minutes delay in the procedure while the user have attempted to troubleshoot the handpiece.The doctor eventually shifted to using bipolar loop resection to break apart tissue into smaller pieces then used the ellik evacuator to remove them.The scheduled procedure was completed, and no additional treatment was required.

• 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: anja ehrenfeuchter ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 25334249
• Report Number: 9611102-2026-00022
• Device Sequence Number: 18583731
• Product Code: GEY
• UDI-Device Identifier: 04055207017982
• UDI-Public: 04055207017982
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2026

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
• Operator of Device: Other
• Device Model Number: 8564021
• Device Catalogue Number: 8564.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2026
• Initial Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/27/2022
• 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