BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE TISSUE REMOVAL DEVICE

    MDR report key: 11757649 · Received April 30, 2021

    Report

    Report Number
    1222780-2021-00085
    Event Type
    Death
    Date Received
    April 30, 2021
    Date of Event
    November 1, 2013
    Report Date
    April 30, 2021
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIH
    PMA / PMN Number
    K142029
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6) PERFORMED AN ANALYSIS OF PUBLIC DATABASE AND FOUND A MAUDE ADVERSE EVENT REPORT INVOLVING A (B)(6) PRODUCT FROM 2019. (B)(6) WAS NOT AWARE OF THIS EVENT UNTIL (B)(6) 2021. MDR REPORT KEY: MW5096005 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. ACCORDING TO THE IFU FOR MYOSURE TISSUE REMOVAL DEVICE IN THE FIRST PAGE IN CONTRAINDICATIONS: THE MYOSURE TISSUE REMOVAL SYSTEM SHOULD NOT BE USED WITH PREGNANT PATIENTS OR PATIENTS EXHIBITING PELVIC INFECTION, CERVICAL MALIGNANCIES, OR PREVIOUSLY DIAGNOSED UTERINE CANCER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2013 A PATIENT RECEIVED A PROCEDURE INVOLVING A MYOSURE DURING THE SURGERY AND THE PHYSICIAN USED THE DEVICE AND OTHER INSTRUMENTS TO REMOVE CANCEROUS TISSUE THROUGH THE VAGINA, THUS NOT USING THE MYOSURE CONTAINMENT DEVICE FOR TISSUE REMOVAL. FOR THE NEXT 6 YEARS THE PATIENT HAD NUMEROUS SURGERIES FOR THE REMOVAL OF METASTATIC CANCER AND EVENTUALLY PASSED AWAY DUE TO COMPLICATIONS FROM CANCER. NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649132 MYOSURE TISSUE REMOVAL DEVICE HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC. 10-401

    Patients

    Seq Age Sex Outcome Treatment
    1 Death