BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER STICK M4

    MDR report key: 24074413 · Received January 14, 2026

    Report

    Report Number
    9611102-2026-00001
    Event Type
    Malfunction
    Date Received
    January 14, 2026
    Date of Event
    January 6, 2026
    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

    OVER THE PAST TWO YEARS, (B)(6) HAS REPORTED CASES OF SERIOUS INJURY WITH A SIMILAR FAULT PATTERN. IN THIS REGARD, THE CURRENT CASE IS BEING REPORTED AS A REPORTABLE MALFUNCTION.

    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: THE SUCTION NOZZLE IS LOOSE AND DENTED, AND BROKEN AT THE LASER WELD SEAM. THE VALVE BORE ON THE HOUSING IS SEVERELY DENTED. 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 IN 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 DAMAGE FOUND ON THE SUCTION MANIFOLD AND VALVE BORE INDICATES MECHANICAL INFLUENCES DUE TO USER ERROR. THE USER IS ADVISED IN IFU GA-A238-US/ EN / 2020-12 V6.0 / PK20-0352 TO RUN THROUGH THE CHECKS BEFORE AND AFTER EACH USE AND TO NOT USE THE PRODUCTS IF THEY ARE DAMAGED OR INCOMPLETE OR HAVE LOOSE PARTS. CHAPTER 7.2.1 OF GA-A238-US / EN /2020-12 V6.0 / PK20-0352 ADVISES USERS TO HAVE THE PRODUCTS SERVICED DEPENDING ON THE FREQUENCY OF USE, BUT AT LEAST EVERY 12 MONTHS, IN ORDER TO PREVENT DAMAGE DUE TO AGING AND WEAR. MANUFACTURING ANALYSIS: THE MOTOR HANDPIECE MAX. 6000RPM WITH SERIAL NUMBER (B)(6) WAS MANUFACTURED ON AUGUST 25, 2021, 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 NOVEMBER 8, 2021. A REVIEW OF THE PRODUCTION PLANS REVEALED NO ANOMALIES. HISTORICAL DATA ANALYSIS: THE MOTOR HANDPIECE MAX. 6000RPM WITH SERIAL NUMBER (B)(6) HAD BEEN WITH THE CUSTOMER SINCE DELIVERY; THERE HAD BEEN NO REPAIRS OR MAINTENANCE. 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 AT THE BEGINNING OF THE MORCELLATION PROCEDURE. A SIMILAR BACK-UP DEVICE WAS UTILIZED, AND THE SCHEDULED PROCEDURE WAS COMPLETED WITH MINIMAL DELAY. THERE WAS NO ADDITIONAL MEDICAL TREATMENT OR PROCEDURE REQUIRED. THERE IS NO REPORT OF INJURY TO THE PATIENT OR OTHER PERSONNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135829 POWER STICK M4 MOTOR HANDPIECE MAX. 6000RPM GEY RICHARD WOLF GMBH 8564021 04055207017982

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown