BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACESSA PROVU SYSTEM

    MDR report key: 17259210 · Received July 5, 2023

    Report

    Report Number
    1222780-2023-00221
    Event Type
    Malfunction
    Date Received
    July 5, 2023
    Date of Event
    August 17, 2021
    Report Date
    July 5, 2023
    Manufacturer
    HOLOGIC, INC
    Product Code
    HFG
    PMA / PMN Number
    K181124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: 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. H3: 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. MW 5103568 RELATED TO THIS EVENT.

    Description of Event or Problem · 0

    DURING A MAUDE DATABASE SEARCH ON (B)(6)2023, HOLOGIC FOUND A VOLUNTARY SUBMISSION MW 5103568 IN WHICH COULD NOT CONFIRM IT HAD BEEN LOGGED IN THE RECORDS SO IN AN ABUNDANCE OF CAUTION DECIDED TO GENERATE A REPORT AND SUBMISSION. IT WAS REPORTED THAT ON (B)(6) 2021, PROVIDER WAS PERFORMING A LAPAROSCOPIC REMOVAL AND ABLATION OF INTRAUTERINE FIBROIDS USING THE ACESSA PROVU GENERATOR AND HANDPIECE. TWO MANUFACTURER REPRESENTATIVES WERE PRESENT. MID-PROCEDURE THE PROVIDER ATTEMPTED TO ACTIVATE THE ABLATION PROBE, BUT THE ACESSA PROVU GENERATOR FAILED TO FUNCTION. THE HOLOGIC REPRESENTATIVE ATTEMPTED TO TROUBLESHOOT THE GENERATOR BUT WAS UNABLE TO REACH A SOLUTION. THE FAILURE RESULTED IN THE PROVIDER BEING UNABLE TO REMOVE ALL THE INTENDED FIBROIDS WHICH MAY REQUIRE THE PATIENT TO UNDERGO A SECOND SURGICAL PROCEDURE. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1786190 ACESSA PROVU SYSTEM COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) HFG HOLOGIC, INC 7100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown