BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE TISSUE REMOVAL DEVICE

    MDR report key: 1855160 · Received September 30, 2010

    Report

    Report Number
    3006659293-2010-00002
    Event Type
    Injury
    Date Received
    September 30, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 30, 2010
    Manufacturer
    INTERLACE MEDICAL INC.
    Product Code
    HIH
    PMA / PMN Number
    K091100
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONFIRMED THAT THE EVENT WAS CAUSED BY USER ERROR; THERE WAS NO DEVICE MALFUNCTION, THEREFORE NO EVALUATION OF THE DEVICE IS WARRANTED. METHOD - INVESTIGATION CONSISTED OF A PHONE INTERVIEW OF THE TREATING PHYSICIAN AND A REVIEW OF THE PHYSICIAN'S OPERATIVE REPORT. RESULTS - A PHONE INTERVIEW OF THE TREATING PHYSICIAN AND REVIEW OF THE PHYSICIAN'S OPERATIVE REPORT REVEALED THAT THE PHYSICIAN PUSHED TOO HARD WITH THE MYOSURE DEVICE WHEN PROBING AT THE BASE OF THE TARGET PATHOLOGY, THEREBY CAUSING PERFORATION OF THE ATTENUATED FUNDAL WALL OF THE UTERUS. THE MYOSURE DEVICE PERFORMED IN ACCORDANCE WITH ITS SPECIFICATIONS. THERE WAS NO DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    THE MYOSURE DEVICE WAS BEING USED TO RESECT A LARGE (APPROX. 4CM) SUBMUCOSAL FIBROID LOCATED IN THE SUPERIOR RIGHT ANTERIOR PORTION OF THE UTERUS. AFTER A LARGE PORTION OF THE FIBROID WAS RESECTED, THE PHYSICIAN ATTEMPTED TO USE THE MYOSURE DEVICE AS A PROBE (THE DEVICE WAS NOT ACTIVELY CUTTING) TO GAIN ACCESS TO THE BASE OF THE FIBROID. WHILE ENGAGED IN THIS ACTIVITY, THE DEVICE PERFORATED THE ANTERIOR FUNDUS. THE PATIENT, WHO HAD PREVIOUSLY BEEN SCHEDULED FOR A LAPAROSCOPY IMMEDIATELY FOLLOWING THE HYSTEROSCOPIC MYOMECTOMY, WAS CONVERTED TO A MINI LAPAROTOMY AT WHICH TIME DIGITAL PRESSURE WAS USED TO STOP BLEEDING AT THE PERFORATION SITE AND 3 SIMPLE 4-0 SILK STITCHES WERE USED TO OVERSEW A SUPERFICIAL SEROSAL DEFECT OF THE SMALL BOWEL ILEUM. A MULTIPLE MYOMECTOMY PROCEDURE WAS ALSO PERFORMED TO REMOVE A: 6 CM SUBMUCOSAL FIBROID, 2 CM SUBMUCOSAL FIBROID, 5 CM SUBSEROSAL FIBROID AND TWO SMALLER INTRAMURAL FIBROIDS. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND RETURNED HOME ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOSURE TISSUE REMOVAL DEVICE HYSTEROSCOPE AND ACCESSORIES HIH INTERLACE MEDICAL INC. NA 100323-112

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention