BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER STICK M4

    MDR report key: 23916671 · Received December 29, 2025

    Report

    Report Number
    9611102-2025-00063
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 16, 2025
    Report Date
    February 25, 2026
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEY
    UDI-DI
    04055207017982
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE HANDPIECE WAS INVESTIGATED AND THE REPORTED CONDITION WAS CONFIRMED. THE CONNECTOR PINS ON THE PLUG ARE SEVERELY CORRODED. ACCORDING TO RICHARD WOLF GMBH TEST INSTRUCTION 8564021PA, THE MOTOR FUNCTION IS IN WORKING ORDER. ADDITIONAL FINDINGS: THERE IS MINIMAL LEAKAGE AT THE ADHESIVE JOINT BETWEEN THE SUCTION PIPE AND THE HOUSING. PROBABLE ROOT CAUSE: THE PROBABLE ROOT CAUSE WAS DETERMINED TO BE A USER ERROR. THE CORRODED CONNECTOR PINS ARE TRACED BACK TO A CLEANING/MAINTENANCE ERROR. THE USER IS ADVISED IN THE INSTRUCTION FOR USE (IFU), GA-A238-US / EN / 2020-12 V6.0 / PK20-0352, CHAPTER 7.3.1, THAT THE ELECTRICAL CONTACTS ON THE CONNECTION CABLE MUST BE COMPLETELY DRY AFTER CLEANING. WITH REGARD TO THE CURRENT CONDITION OF THE CONNECTOR PINS, WE ASSUME THAT LIQUIDS WERE NOT COMPLETELY REMOVED WHEN THE CONNECTION CABLE WAS CONTACTED, RESULTING IN CORROSION. THE CORRODED CONNECTOR PINS MAY BE RESPONSIBLE FOR THE FUNCTIONAL IMPAIRMENTS THAT THE USER HAS NOTICED. THE MOST LIKELY CAUSE OF THE LEAK IS AGING OR MICROCRACKS IN THE HOUSING DUE TO MECHANICAL STRESS. IN CHAPTER 1.5, THE USER IS ADVISED THAT "RAPID COOLING OF A HOT MOTORIZED HANDLE CAN CAUSE STRESSES IN THE MATERIAL AND MAY LEAD TO FAILURE OF THE DEVICE OR A REDUCED SERVICE LIFE." IN CHAPTER 7.2.1 OF GA-A238-US / EN/ 2020-12 V6.0 / PK20-0352, THE USER IS ADVISED OF MAINTENANCE INTERVALS TO AVOID DAMAGE DUE TO AGEING OR WEAR. MANUFACTURING ANALYSIS: THE MOTOR HANDPIECE MAX. 6000RPM WITH SERIAL NUMBER (B)(6) WAS MANUFACTURED ON DECEMBER 27, 2022, WITH ORDER NUMBER (B)(4). THE ORDER SIZE WAS (B)(4) UNITS. THE MOTOR HANDLE MAX. 6000RPM WITH SERIAL NUMBER (B)(6) WAS DELIVERED TO THE CUSTOMER ON MAY 22, 2023. A REVIEW OF THE PRODUCTION PLANS REVEALED NO ANOMALIES. HISTORICAL DATA ANALYSIS: THE MOTOR HANDPIECE MAX. 6000RPM WITH SERIAL NUMBER (B)(6) WAS LAST REPAIRED ON JUNE 23, 2023, IN WHICH THE PLUG WAS REPLACED DUE TO CORROSION, AND THE SUCTION PIPE WAS ALSO REPLACED. 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, V00. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSTRUMENT HAS LOST SUCTION DURING THE END OF THE PROCEDURE. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL. HOWEVER, THE REPORTED ISSUE CAUSED A 25 - 35 MINUTES DELAY IN THE PROCEDURE WHILE THE USER HAVE ATTEMPTED MULTIPLE TIMES TO FLUSH THE HANDPIECE. THE SCHEDULED PROCEDURE WAS COMPLETED, AND NO ADDITIONAL TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24133 POWER STICK M4 MOTOR HANDPIECE MAX. 6000RPM GEY RICHARD WOLF GMBH 8564021 04055207017982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown