BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 2872120 · Received December 6, 2012

    Report

    Report Number
    1222780-2012-00261
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 7, 2012
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K100559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER OF THE DISPOSABLE DEVICE WAS NOT PROVIDED BY THE COMPLAINANT, THEREFORE THE EXP 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 MFR DATE IS NOT KNOWN. DEVICE HISTORY RECORD (DHR) REVIEWS WERE NOT ABLE TO BE CONDUCTED FOR THE MYOSURE SYSTEM AS PRODUCT IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    DURING A MYOSURE PROCEDURE FOR THE REMOVAL OF A 4CM FIBROID IT WAS NOTED ¿THE PT WAS BLEEDING HEAVILY.¿ SEVENTY PERCENT OF THE FIBROID HAD BEEN REMOVED WHEN THE BLEEDING OCCURRED. THEY ATTEMPTED TO USE A FOLEY CATHETER TO STEM THE BLEEDING WITHOUT SUCCESS. THE PHYSICIAN ABORTED THE PROCEDURE AND PERFORMED A HYSTERECTOMY (ADMISSION AND DISCHARGE DATES UNK). ON (B)(6) 2012, IT WAS REPORTED THAT NO UTERINE PERFORATION SEEN DURING A POST HYSTERECTOMY PATHOLOGY EXAM. ON (B)(6) 2012, IT WAS REPORTED ¿THE PT IS DOING WELL.¿

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R SALINE USED AS DISTENSION MEDIA| MYOSURE HYSTEROSCOPE: SERIAL NUMBER UNK| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM:| CONTROL UNIT-SERIAL# UNK