BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACESSA PROVU HANDPIECE

    MDR report key: 13993980 · Received April 4, 2022

    Report

    Report Number
    3006443171-2022-00004
    Event Type
    Injury
    Date Received
    April 4, 2022
    Report Date
    April 4, 2022
    Manufacturer
    ACESSA HEALTH INC.
    Product Code
    HFG
    PMA / PMN Number
    K181124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    LOT AND SERIAL NUMBER OF THE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE UDI, EXPIRATION AND MANUFACTURING DATES ARE NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE CONDUCTED FOR THE DISPOSABLE DEVICE AS THE IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE INVOLVED IN THIS EVENT WAS NOT RETURNED FOR EVALUATION PURPOSES THEREFORE VISUAL AND FUNCTIONAL ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED. WE ARE UNABLE TO CONFIRM A RELATIONSHIP BETWEEN THE DEVICE AND THE ISSUE REPORTED AND A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. THE INFORMATION OBTAINED DURING COMPLAINT INVESTIGATION WILL BE INCLUDED IN OUR GLOBAL COMPLAINT TRENDING AND PRODUCT SURVEILLANCE WILL CONTINUE TO MONITOR COMPLAINTS OF THIS TYPE FOR ADVERSE TRENDS. IF THE PRODUCT IS RECEIVED OR ADDITIONAL INFORMATION IS OBTAINED, THE INVESTIGATION WILL BE REOPENED ACCORDINGLY PER STANDARD OPERATING PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT RECEIVED AN ACESSA PROVU PROCEDURE AND THAT THE PATIENT LATER DEVELOPED AN INFECTION. THE INFECTION WAS DRAINED AND TREATED WITH IR AND THE PATIENT IS STILL EXPERIENCING PAIN. THE PATIENT RECEIVED AN ULTRASOUND THAT REVEALED THAT THE FIBROIDS HAD REDUCED SIZE. NO NECROTIC TISSUE WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82997 ACESSA PROVU HANDPIECE COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) HFG ACESSA HEALTH INC. 7300

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other ACESSA PROVU CONSOLE