BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIEZOSURGERY

    MDR report key: 14344894 · Received May 10, 2022

    Report

    Report Number
    3003933619-2022-00002
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    February 10, 2022
    Report Date
    July 21, 2022
    Manufacturer
    MECTRON S.P.A.
    Product Code
    JDX
    PMA / PMN Number
    K153743
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MECTRON CARRIED OUT FUNCTIONAL TESTING WITH THE RETURNED HANDPIECES (SEE TEST REPORT (B)(4)). NO NEED TO INITIATE ANY KIND OF ACTIONS BECAUSE THE TESTING RESULTS DID NOT RAISE ANY CONCERNS. MECTRON SHIPPED BACK THE DEVICE TO THE CUSTOMER AND SENT THE OUTCOME OF THE INVESTIGATION WITH THE TEST REPORT ON (B)(6) 2022. NO ROOT CAUSE CAN BE REPORTED BECAUSE THE RESULTS OF THE FUNCTIONAL TESTING CARRIED OUT WITH THE RETURNED DEVICE, DID NOT RAISE ANY MALFUNCTIONS, DEFECTS OR OTHER ISSUES.

    Additional Manufacturer Narrative · 0

    MECTRON CARRIED OUT FUNCTIONAL TESTING WITH THE RETURNED HANDPIECES (SEE TEST REPORT (B)(4)). NO NEED TO INITIATE ANY KIND OF ACTIONS BECAUSE THE TESTING RESULTS DID NOT RAISE ANY CONCERNS. MECTRON SHIPPED BACK THE DEVICE TO THE CUSTOMER AND SENT THE OUTCOME OF THE INVESTIGATION WITH THE TEST REPORT ON 09/05/2022. NO ROOT CAUSE CAN BE REPORTED BECAUSE THE RESULTS OF THE FUNCTIONAL TESTING CARRIED OUT WITH THE RETURNED DEVICE, DID NOT RAISE ANY MALFUNCTIONS, DEFECTS OR OTHER ISSUES. NO ADDITIONAL INFORMATIONS RECEIVED FROM THE CUSTOMERS THEREFORE THE COMPLAIN IS CLOSED ON 21/07/2022.

    Description of Event or Problem · 0

    PAMS GET SO HOT AND FAST THAT YOU CAN'T HOLD THEM IN YOUR HAND.

    Description of Event or Problem · 0

    PAMS GET SO HOT AND FAST THAT YOU CAN'T HOLD THEM IN YOUR HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1095068 PIEZOSURGERY PIEZOSURGERY HANDPIECE JDX MECTRON S.P.A.
    1186128 PIEZOSURGERY PIEZOSURGERY HANDPIECE JDX MECTRON S.P.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown