BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACESSA PROVU HANDPIECE

    MDR report key: 8666181 · Received June 4, 2019

    Report

    Report Number
    3006443171-2019-00001
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    April 29, 2019
    Report Date
    April 29, 2019
    Manufacturer
    ACESSA HEALTH INC.
    Product Code
    HFG
    UDI-DI
    00854763006140
    PMA / PMN Number
    K181124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RETURNED AND EVALUATION CONFIRMED THAT THE DISTAL TIP DETACHED FROM SLOTTED TUBE, CAUSING THE DISTAL TIP AND INSULATING RING TO SEPARATE FROM THE REST OF THE HANDPIECE. ACESSA HEALTH INC. AT THIS TIME HAS NOT DETERMINED THE ROOT CAUSE AS EVALUATION OF THE RETURNED HANDPIECE AND APPLICABLE DOCUMENTATION HAS IDENTIFIED THAT THE DISTAL TIP HAD BEEN ATTACHED CORRECTLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE DISTAL TIP OF THE HANDPIECE IS DESIGNED TO NOT SEPARATE FROM THE HANDPIECE. THIS DETACHMENT HAPPENED OUTSIDE OF THE PATIENT SO THERE WAS NO POSSIBILITY OF PATIENT INJURY. IF THIS WERE TO HAPPEN INSIDE OF THE PATIENT THERE IS POTENTIAL THAT THE DISTAL TIP COULD REMAIN IN THE TREATED AREA AND REQUIRE REMOVAL BY THE PHYSICIAN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE THE DISTAL TIP DETACHED FROM SLOTTED TUBE, CAUSING THE DISTAL TIP AND INSULATING RING TO SEPARATE FROM THE REST OF THE HANDPIECE. THIS HAPPENED OUTSIDE OF THE PATIENT AND IT WAS CONFIRMED THAT NOTHING FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A BACKUP HANDPIECE AND THERE WAS NO REPORT OF PATIENT HARM, INJURY, OR ADVERSE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459123 ACESSA PROVU HANDPIECE ACESSA HFG ACESSA HEALTH INC. 7300 19407418 00854763006140

    Patients

    Seq Age Sex Outcome Treatment
    1