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

Model Number	8564021
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Richard wolf gmbh (rw gmbh) has submitted a comparable reportable serious incident in the last two years and therefore have considered to report this case to be a reportable malfunction.
Event or Problem Description
It was reported that during a procedure, the motor control unit detected the handpiece intermittently, then stopped being detectable.The handpiece was checked and found not functioning properly with the cable or motor control unit.There is no report of injury to the patient or other personnel.However, the reported issue caused a 15 minute delay in the procedure while obtaining another second motor control unit, m4 handpiece and morcellator cable to complete the scheduled procedure.
Additional Manufacturer Narrative
Investigation results: the handpiece was investigated in the department responsible.The test device shows an electrical breakdown at the hall sensor, which causes mass leakage currents.Due to a hairline crack in the weld seam, moisture has penetrated the system, causing a short circuit.Causes: the probable root cause is sporadic failure of the motor handpiece after 5 months of use.The ifu ga-a202 / us /2020-10 v2.0 / pk20-0329 contains several safety instructions and notes regarding the visual and functional checks prior to use in section 4.Manufacturing analysis: the motor handpiece max.6000rpm, 8564021, sn (b)(6) was manufactured with order number 1588118 on september 19, 2024.The order size was (b)(4) pieces.No issue was identified during production.Historical data analysis: over the past two years, there have been (b)(4) deliveries to customers, with two cases of a similar fault occurring during the same period.Two serious injuries with a similar error pattern have been reported in the past 2 years.Risk analysis: the subject issue of functional malfunction/loss of function due to an unusable product is present in the risk management file e5-2: motorized handles, voo.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 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: 22436929
• Report Number: 9611102-2025-00030
• Device Sequence Number: 4708306
• Product Code: GEY
• UDI-Device Identifier: 04055207017982
• UDI-Public: 04055207017982
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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
• 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: 06/26/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Supplement Date Received by Manufacturer: 08/22/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2024
• 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
• Patient Sex: Unknown