BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESOUND

    MDR report key: 2142787 · Received April 8, 2011

    Report

    Report Number
    1222780-2011-00062
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    HOLOGIC
    Product Code
    HHM
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE SURESOUND DEVICE NOT PROVIDED BY THE COMPLAINANT. THE DEVICE IS NOT BEING RETURNED THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE MFR DATE IS NOT KNOWN. BASED ON THE INFO OBTAINED TO DATE, NO DIRECT CORRELATION CAN BE MADE BETWEEN THE REPORTED EVENT AND THE NOVASURE SYSTEM. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED FOR THE SURESOUND DEVICE AS A LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE FIRST OF TWO HOLOGIC DEVICES USED IN THE SAME PROCEDURE. SEE ASSOCIATED MEDWATCH, MFR'S REPORT NUMBER 1222780-2011-00063. FOLLOWING AN UNSUCCESSFUL CAVITY INTEGRITY ASSESSMENT (CIA) TEST DURING A NOVASURE ENDOMETRIAL ABLATION ON A SEVERELY ANTEVERTED UTERUS, THE PROCEDURE WAS ABORTED AND A "SMALL PERFORATION WAS NOTED IN THE FUNDAL OSTIA REGION" DURING A POST HYSTEROSCOPY AND LAPAROSCOPY. THE PHYSICIAN CAUTERIZED THE PERFORATION AND THE PT WAS DISCHARGED THE SAME DAY. A HYSTEROSCOPY WAS PERFORMED PRIOR TO THE ATTEMPTED ABLATION, AS WAS A DILATATION, AND SOUNDING WITH A SURESOUND. IT IS NOT KNOWN WHEN THIS PERFORATION OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURESOUND HHM HOLOGIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other| R