BEUDAMED
    FDA Adverse Event Death Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 3534508 · Received December 10, 2013

    Report

    Report Number
    1222780-2013-00230
    Event Type
    Death
    Date Received
    December 10, 2013
    Date of Event
    December 5, 2013
    Report Date
    December 5, 2013
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K100559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE DISPOSABLE DEVICE NOT PROVIDED BY THE COMPLAINANT, THEREFORE, THE EXPIRATION DATE IS NOT KNOWN. SERIAL NUMBER OF THE MYOSURE CONTROL UNIT AND HYSTEROSCOPE NOT PROVIDED BY THE COMPLAINANT. THE DISPOSABLE 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 NOT ABLE TO BE CONDUCTED FOR THE MYOSURE SYSTEM AS THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PHYSICIAN PERFORMED A HYSTEROSCOPIC MYOMECTOMY IN THE OPERATING ROOM UNDER LARYNGEAL MASK ANESTHESIA WITH A MYOSURE DEVICE ON A PT WITH "REMARKABLE HYPERTENSION, RHEUMATOID ARTHRITIS AND OBESITY (B)(4)". THE PROCEDURE WAS "PERFORMED WITHOUT DIFFICULTY". THE PHYSICIAN STATED "TECHNICAL6Y THE CASE WAS EASY". SUBSEQUENTLY, "[THE PHYSICIAN} WAS NOTIFIED BY THE NURSE ANESTHETIST THAT THE PT'S OXYGEN SATURATION LEVEL WAS DROPPING ALONG WITH HER BLOOD PRESSURE. THE PT WAS INTUBATED AND THE ANESTHESIOLOGIST BEGAN RESUSCITATION EFFORTS. DURING THE CODE, A TRANS-ESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED WHICH DEMONSTRATED A PULMONARY EMBOLISM. ALL RESUSCITATION EFFORTS FAILED AND THE PT EXPIRED. THE MEDICAL EXAMINER NOTIFIED [THE PHYSICIAN] THAT THE CAUSE OF DEATH WAS PULMONARY EMBOLISM WITH CO-MORBIDITIES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643056 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HIH HOLOGIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death SALINE DISTENTION MEDIA| MYOSURE HYSTEROSCOPE - SERIAL NUMBER UNKNOWN| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM| CONTROL UNIT - SERIAL NUMBER UNK