BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE TISSUE REMOVAL DEVICE

    MDR report key: 11757890 · Received April 30, 2021

    Report

    Report Number
    1222780-2021-00093
    Event Type
    Death
    Date Received
    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

    HOLOGIC PERFORMED A ANALYSIS OF PUBLIC DATABASE AND FOUND A MAUDE ADVERSE EVENT REPORT INVOLVING A HOLOGIC PRODUCT FROM 2019. HOLOGIC WAS NOT AWARE OF THIS EVENT UNTIL 04/14/2021. MDR REPORT KEY: (B)(4). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2019, A PATIENT RECEIVED MYOSURE PROCEDURE FOR POST MENOPAUSAL BLEEDING. THE PATIENT UNDERWENT REMOVAL OF AN ENDOMETRIAL MASS AND DILATATION AND CURETAGE. THE AQUILEX FLUID MANAGEMENT SYSTEM WAS USED FOR IRRIGATION AND THERE WAS FLUID DEFICIT OF 2194 ML OF IRRIGANT AND A SMALL UTERINE PERFORATION WAS NOTED DURING THE CASE. PATIENT WAS STABLE OVERNIGHT WITH INCREASING ABDOMINAL PAIN AND THEN BECAME ACUTELY HYPOTENSIVE, PROGRESSING QUICKLY TO REQUIRING 3 PRESSORS. AT THAT POINT, GENERAL SURGERY TOOK HER TO THE OPERATING ROOM FOR EXPLORATORY LAPAROSCOPY AND WAS FOUND TO HAVE A SMALL BOWEL PERFORATION WITH EXTENSIVE FECULENT MATERIAL IN THE ABDOMEN. PATIENT REQUIRED PRESSORS BUT REMAINED ACIDOTIC AND WENT INTO CARDIAC ARREST WITH RESTORATION OF PULSE. CONDITION CONTINUED TO DETERIORATE AND PATIENT EXPIRED TWO DAYS POST SURGERY. NO MALFUNCTION OF THE DEVICE WAS NOTED OR SUSPECTED. NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651051 MYOSURE TISSUE REMOVAL DEVICE HYSTEROSCOPE (AND ACCESSORIES) HIH HOLOGIC, INC. 30-401LITE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death