BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER STICK M5/3

    MDR report key: 17109392 · Received June 12, 2023

    Report

    Report Number
    9611102-2023-00034
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    March 13, 2023
    Report Date
    June 12, 2023
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    GEY
    PMA / PMN Number
    K080617
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING THE INSPECTION OF THE MOTOR HANDLE IN THE SPECIALIST DEPARTMENT IN ACCORDANCE WITH PA-01-001-8874, IT WAS FOUND THAT THE BELLOWS OF THE MOTOR GEAR UNIT IS SEVERELY DEFORMED AND DOES NOT RUN SMOOTHLY. THERE IS AN UNBALANCE PRESENT. MOTORIZED HANDLE TYPE 899550003 WITH SERIAL NUMBER (B)(6) WAS PRODUCED ON 11/17/2021 (BATCH 1493848 WITH A LOT SIZE OF 15) AND DELIVERED TO THE CUSTOMER ON 11/24/2021. REVIEW OF THE DEVICE HISTORY RECORD DID NOT IDENTIFY ANY DISCREPANCIES OR SPECIAL RELEASES. IN THE PERIOD UNDER CONSIDERATION, NO COMPARABLE CASE OF THIS TYPE 89955.0003 WITH "COIL - SHORT CIRCUIT" HAS BEEN REGISTERED. IN GENERAL, THE USER IS ADVISED IN THE ASSOCIATED GA-A238-US / EN / 2020-12 V6.0 / PK20-0352 INSTRUCTIONS FOR USE UNDER CHAPTER 4 THAT A VISUAL AND FUNCTIONAL CHECK MUST BE PERFORMED BEFORE AND AFTER EACH USE. POSSIBLE DAMAGE/MALFUNCTIONS OF THE ABOVE TYPE CAN BE EASILY DETECTED BY HOSPITAL STAFF IF THESE INSTRUCTIONS ARE FOLLOWED. IN OUR RISK ANALYSIS E5-2, MANUFACTURING-RELATED, HANDLING-RELATED AND DESIGN-RELATED HAZARDS WITH REGARD TO A FUNCTIONAL IMPAIRMENT AS WELL AS RISKS DUE TO AN UNUSABLE PRODUCT WITH THE CORRESPONDING EXTENT OF DAMAGE AND THE ASSUMED PROBABILITY OF OCCURRENCE WERE CONSIDERED AND ASSESSED WITH AN ACCEPTABLE RISK.

    Description of Event or Problem · 0

    A HEALTH PROFESSIONAL HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A MOTOR HANDPIECE MAX. 16000RPM, PART ID: 899550003, SERIAL # (B)(6). ACCORDING TO THE RECEIVED INFORMATION, "WHEN USING THE BENCH DRILL IT STOPPED ROTATING AND DID NOT PERFORM ITS FUNCTION." THE REPORTED ISSUE CAUSED A 2 HOUR DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF RISK FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482292 POWER STICK M5/3 MOTOR HANDPIECE MAX. 16000RPM GEY RICHARD WOLF GMBH 899550003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown