BEUDAMED
    FDA Adverse Event Other Summary report: N

    PIEZOSURGERY

    MDR report key: 2824513 · Received October 5, 2012

    Report

    Report Number
    3003933619-2012-00001
    Event Type
    Other
    Date Received
    October 5, 2012
    Date of Event
    September 30, 2012
    Report Date
    September 13, 2012
    Manufacturer
    MECTRON S.P.A.
    Product Code
    ELC
    PMA / PMN Number
    K052518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REPORTED A SLIGHT BURN TO THE SOFT TISSUE (LIP) AND THE USER INFORMED THE DISTRIBUTOR THAT THE INJURY ON PT WAS MINOR AND DID NOT CAUSE FOR ANY ADD¿L TREATMENT OR HOSPITALIZATION. ON (B)(4) 2012, THE MECTRON (B)(4). RECEIVED THE HAND PIECE SERIAL NUMBER (B)(4) SUBJECT OF COMPLAINT AND AN INVESTIGATION HAS BEEN CARRIED OUT. THE SERIAL NUMBER OF THE HAND PIECE CORRESPOND TO THE MFG DATE 07/31/2006: THE DATA CONTAINED IN THE PAPERS WORK AND THE FINAL TESTING VISUAL AND FUNCTIONAL SHOW THAT HAND PIECE WAS MANUFACTURED IN CONFORMITY WITH THE DESIGN REQUIREMENTS. THE TECHNICAL SERVICE SPECIALIST OF MECTRON (B)(4) HAS TESTED VISUALLY AND FUNCTIONALLY THIS HAND PIECE AND NO ABNORMALITIES WERE NOTED. THE HAND PIECE WORKS CORRECTLY. THE FUNCTION R&D HAD EXAMINED THE HAND PIECE. TESTS WERE CARRIED OUT WITH DEEP CUTTING INSERT AND TEST DRILLING INSERT: EVEN UNDER STRESS HAND PIECE WORKED PROPERLY AND NO PROBLEM WAS NOTED. THE HAND PIECE WORKS APPROPRIATELY. THEREFORE WE DON¿T HAVE ANY INFO ON ORAL SURGERY PROCEDURE USED ON PT AND WE DON¿T HAVE SUFFICIENT INFO TO DETERMINE WITH CERTAINTY WHETHER THE PT¿S HARDSHIP WAS CAUSED BY OUR DEVICE OR BY THE USER.

    Description of Event or Problem · 1

    THE EVENT IS DESCRIBED IN THE MEDWATCH (B)(4): ¿AN USER FACILITY ((B)(4)) WAS PERFORMING AN UNK ORAL SURGERY PROCEDURE ON A PT USING A PIEZOSURGERY/DENTAL DEVICE. THE PT THEN COMPLAINED OF A SLIGHT BURN TO THE SOFT TISSUE (LIP). COMPATIBLY, WITH IMPROPER USE OF THE DEVICE CONTRARY TO THE MFR¿S CLEARLY STATED GUIDELINES, THERE CAN BE DAMAGE TO THE SOFT TISSUE. FROM WHAT THE USER FACILITY HAS INFORMED US, THE INJURY WAS MINOR AND DID NOT CAUSE FOR ANY ADD¿L TREATMENT OR HOSPITALIZATION. WE ARE ASSUMING THE WOUND HEALED ON ITS OWN. WE HAVE MADE SEVERAL ATTEMPTS TO GET MORE INFO FROM THE USER FACILITY; HOWEVER, THEY ARE NOT COOPERATING. THEY CONTINUE TO NOT RETURN OUR CALLS. THEREFORE, AT THIS TIME, WE DO NOT HAVE SUFFICIENT INFO TO DETERMINE WITH CERTAINTY WHETHER THE PT¿S HARDSHIP WAS CAUSED BY THE PIEZOSURGERY/DENTAL DEVICE OR BY PHYSICIAN ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PIEZOSURGERY HANDPIECE TO PIEZSURGERY ELC MECTRON S.P.A. PIEZOSURGERY// NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK