BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 8180959 · Received December 19, 2018

    Report

    Report Number
    1222780-2018-00257
    Event Type
    Death
    Date Received
    December 19, 2018
    Date of Event
    November 14, 2018
    Report Date
    November 20, 2018
    Manufacturer
    HOLOGIC, INC.
    Product Code
    HIH
    PMA / PMN Number
    K122498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND SERIAL NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. THE DEVICE IS NOT BEING RETURNED; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT; THEREFORE, THE MANUFACTURE DATE IS 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. INTERNAL COMPLAINT REFERENCE: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2018 A MYOSURE TISSUE REMOVAL PROCEDURE WITH AQUILEX FLUID MANAGEMENT WAS PERFORMED. PRIOR TO THE MYOMECTOMY THE PHYSICIAN PERFORMED A LAPAROSCOPIC SALPINGECTOMY. ACCORDING TO THE CLINICAL ACCOUNT MANAGER, "THERE WAS FLUID ON THE FLOOR SO THE GYN COORDINATOR DID A MANUAL COUNT WHICH WAS 2100CC." "THE PROCEDURE WENT ALONG AS NORMAL AND UPON LEAVING THE PATIENT'S VITAL SIGNS WERE ALL NORMAL." THE CLINICAL ACCOUNT MANAGER RECEIVED A CALL ON (B)(6) 2018 FROM THE GYN COORDINATOR TO REPORT THAT THE PATIENT WAS FOUND UNRESPONSIVE AT HOME ON (B)(6) 2018 AND WAS TRANSPORTED TO THE EMERGENCY ROOM AND SUBSEQUENTLY EXPIRED. THE PRESUMPTIVE DIAGNOSIS WAS PULMONARY EMBOLISM WHICH WAS ULTIMATELY CONFIRMED ON AUTOPSY. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 REPORTED THAT THE PATIENT WAS UNABLE TO HAVE A BOWEL MOVEMENT FOR 5 DAYS POST OPERATIVELY AND CALLED THE PHYSICIAN. SHE SPOKE WITH A PARTNER OF THE PHYSICIAN AND WAS ADVISED TO USE A SUPPOSITORY. THE AUTOPSY REPORT DETERMINED MULTIPLE PULMONARY EMBOLI IN THE CHEST. BASED ON FOLLOW-UP THE MEDICAL DIRECTOR'S JUDGEMENT IS THAT THE MYOSURE XL AND AQUILEX SYSTEMS DID NOT CAUSE OR CONTRIBUTE TO A SERIOUS INJURY NOR DOES THE INFORMATION INDICATE A MALFUNCTION OF EITHER DEVICE THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO THIS EVENT. PELVIC SURGERY OF ANY TYPE CAN LEAD TO PE BUT THE RISK OF PE IS NOT DIRECTLY RELATED TO THE DEVICE(S) USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021916 MYOSURE XL HYSTEROSCOPIC TISSUE REMOVAL SYSTEM UTERINE TISSUE REMOVAL SYSTEM HIH HOLOGIC, INC. 50-501XL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Death MYOSURE CONTROL UNIT: SN UNKNOWN