BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN INTACT HANDLE

    MDR report key: 7252046 · Received February 8, 2018

    Report

    Report Number
    1226420-2018-00032
    Event Type
    Injury
    Date Received
    February 8, 2018
    Date of Event
    December 1, 2012
    Report Date
    February 8, 2018
    Manufacturer
    MEDTRONIC ADVANCED ENERGY, LLC
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) PATIENT INFORMATION INCOMPLETE AND MISSING PATIENT INFORMATION UNABLE TO BE OBTAINED DESPITE A GOOD FAITH EFFORT MADE TO OBTAIN THE INFORMATION FROM THE CUSTOMER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ARTICLE TITLE: THE INTACT BREAST LESION EXCISION SYSTEM AS A THERAPEUTIC DEVICE FOR SELECTED BENIGN BREAST LESIONS DOI: 10.1111/TBJ.12931 THE AIM OF THIS PAPER IS TO EVALUATE OUR UNIT¿S INITIAL EXPERIENCE USING THE INTACT BREAST LESION EXCISION SYSTEM AS A THERAPEUTIC EXCISION OPTION FOR BENIGN OR BORDERLINE BREAST LESIONS, WHICH OTHERWISE WOULD ENTAIL OPEN OPERATIVE EXCISION. THE STUDY INCLUDES THE FIRST 111 PATIENTS WHO UNDERWENT THERAPEUTIC EXCISION WITH THE INTACT RADIOFREQUENCY SYSTEM BETWEEN DECEMBER 2012 AND MAY 2016 PERFORMED AT THE MEIRAV CENTER FOR BREAST HEALTH, AT THE CHAIM SHEBA MEDICAL CENTER, RAMAT GAN ISRAEL. THE INDICATIONS FOR THE PROCEDURE INCLUDED THOSE PATIENTS WHO HAVE BENIGN, OR ATYPICAL HIGH RISK LESIONS FOLLOWING A PREVIOUS CORE NEEDLE BIOSPY (CNB) WHO WOULD HAVE NORMALLY UNDERGONE CONVENTIONAL EXCISION BIOPSY. AFTER REVIEWING EACH CASE SEPARATELY, WE FOUND THAT THE USE OF THE BLES SYSTEM AS A TREATMENT DEVICE PERMITTED THE AVOIDANCE OF OPERATIONS THAT WOULD HAVE BEEN OTHERWISE INDICATED, IN 98 CASES OF THE TOTAL 111 IN THE COHORT (88.3%). THIRTEEN CASES EVENTUALLY HAD TO UNDERGO SURGICAL EXCISION. IN EIGHT CASES PATHOLOGY WAS UPGRADED FROM THE INITIAL CNB TO INVASIVE OR NONINVASIVE CARCINOMA. ALTHOUGH THE INTACT SYSTEM IS MOST COMMONLY USED AS AN ALTERNATIVE BIOPSY TECHNIQUE FOR ITS DIAGNOSTIC CAPABILITIES, THIS STUDY ASSESSED ITS CLINICAL ROLE AS A DEFINITIVE THERAPEUTIC EXCISIONAL MODALITY IN SELECTED CASES OF BENIGN BREAST DISEASE. IT PROVED VALUABLE IN THE MAJORITY OF CASES WITH AVOIDANCE OF SURGERY WHERE IT WAS ADDITIONALLY INDICATED, (98/111, 88.3%) AND AS DEFINITIVE FIBROADENOMA MANAGEMENT IN A FURTHER 28 PATIENTS. FOUR PATIENTS IN THE COHORT DEVELOPED A HEMATOMA NEAR THE NEEDLE ENTRY SITE WHOM WERE SUCCESSFULLY MANAGED CONSERVATIVELY. FORMATION OF A HEMATOMA WAS THE ONLY OBSERVED COMPLICATION IN THE STUDY. THERE WERE NO PATIENT IDENTIFIERS WITHIN THE ARTICLE, THEREFORE THE PATIENTS WILL BE REPORTED AS A WHOLE AND NO OTHER RECORDS WILL BE CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97462 UNKNOWN INTACT HANDLE INSTRUMENT, BIOPSY KNW MEDTRONIC ADVANCED ENERGY, LLC MAE UNK INTACT HDL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention