BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACESSA PROVU HANDPIECE

    MDR report key: 17612779 · Received August 24, 2023

    Report

    Report Number
    1222780-2023-00281
    Event Type
    Death
    Date Received
    August 24, 2023
    Date of Event
    August 17, 2023
    Report Date
    August 24, 2023
    Manufacturer
    HOLOGIC, INC
    Product Code
    HFG
    UDI-DI
    15420045515246
    PMA / PMN Number
    K181124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    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. H6: HEALTH EFFECT CLINICAL CODE- SUGGESTED CODE : UTERINE RUPTURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT RECEIVED AN ACESSA PROCEDURE ONE AND A HALF YEARS AGO (EARLY 2022), WITH NO COMPLICATIONS, AND THAT PATIENT BECAME PREGNANT AND AT 31 WEEKS AND 6 DAYS SUFFERED A UTERINE RUPTURE. PATIENT RECEIVED SURGERY TO REPAIR THE RUPTURE ONE MONTH AGO. PATIENT DID NOT HAVE A HYSTERECTOMY. ADDITIONAL INFORMATION WAS RECEIVED , THE MOTHER WAS STABLE AFTER THE UTERINE REPAIR AND REQUIRED A POSTERIOR RUPTURE , PATIENT HAD A PREVIOUS POSTERIOR FIBROID 3X3 TREATED WITH ACESSA, AFTER THE RUPTURE THE PATIENT DID NOT REQUIRE ANY ADDITIONAL IMAGING OR SURGERY. NO LOT NUMBER AVAILABLE. SADLY THE BABY WAS REPORTED TO HAVE PASSED AWAY AT THE TIME OF THE UTERINE RUPTURE. NO OTHER INFORMATION IS AVAILABLE. THE DATE OF THE ACESSA PROCEDURE IS UNKNOWN AS WELL AS THE DATE OF THE UTERINE RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2090297 ACESSA PROVU HANDPIECE COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) HFG HOLOGIC, INC 7300 15420045515246

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death