BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE ROD LENS HYSTEROSCOPE

    MDR report key: 2894018 · Received December 20, 2012

    Report

    Report Number
    1222780-2012-00277
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 20, 2012
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K091465
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SERIAL NUMBER OF THE MYOSURE HYSTEROSCOPE NOT PROVIDED BY THE COMPLAINANT. THE MYOSURE HYSTEROSCOPE IS NOT BEING RETURNED, THEREFORE, A FAILURE ANALYSIS OF THE HYSTEROSCOPE CAN NOT BE COMPLETED. DEVICE HISTORY RECORD (DHR) REVIEW WAS NOT ABLE TO BE CONDUCTED FOR THE MYOSURE HYSTEROSCOPE AS PRODUCT IDENTIFICATION NUMBERS WERE NOT PROVIDED BY THE COMPLAINANT. (B)(4).

    Description of Event or Problem · 1

    PRIOR TO A MYOSURE PROCEDURE FOR UTERINE TISSUE REMOVAL, THE PHYSICIAN PERFORMED A HYSTEROSCOPY TO LOCATE A "MASS OF DARK TISSUE ON THE UTERINE WALL", WHICH WAS REVEALED ON THE PT'S ULTRASOUND. THE PHYSICIAN "BELIEVED THE MASS WAS A DEAD FIBROID". DURING THE HYSTEROSCOPY, THE PHYSICIAN "BUMPED INTO THE MASS WITH THE MYOSURE SCOPE AND KNOCKED THE MASS LOOSE FROM THE UTERINE WALL." THERE WAS BLEEDING IN THE UTERINE CAVITY AND A FLUID DEFICIT OF 2085CC. SALINE WAS USED AS THE DISTENTION MEDIUM. THE PHYSICIAN SUSPECTED A PERFORATION AND ABORTED THE PROCEDURE. "THE PT WAS IN GOOD HEALTH AND VITAL [SIGNS] WERE GOOD." THERE WAS NO INTERVENTION REQUIRED. ON (B)(6) 2012, IT WAS REPORTED THE PT WAS DISCHARGED HOME AFTER THE PROCEDURE WAS ABORTED AND THE PT IS "DOING FINE." A DILATATION, AND SOUNDING WITH A METAL SOUND (NOT HOLOGIC DEVICES) WERE PERFORMED PRIOR TO THE PROCEDURE. IT IS NOT KNOWN WHEN THIS SUSPECTED PERFORATION OCCURRED OR WHAT INSTRUMENT MAY HAVE BEEN THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOSURE ROD LENS HYSTEROSCOPE HIH HOLOGIC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SALINE DISTENTION MEDIA| AQUILEX FLUID CONTROL SYSTEM - SERIAL # UNK