BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYOSURE TISSUE REMOVAL DEVICE

    MDR report key: 1714542 · Received June 3, 2010

    Report

    Report Number
    3006659293-2010-00001
    Event Type
    Malfunction
    Date Received
    June 3, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 3, 2010
    Manufacturer
    INTERLACE MEDICAL, INC.
    Product Code
    HIH
    PMA / PMN Number
    K091100
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION OF THE RETURNED MYOSURE COMPLAINT DEVICE REVEALED AN ESSURE COIL HANGING FROM THE END OF A CLOSED CUTTING WINDOW. THE MYOSURE CUTTER BLADE WAS RETRACTED BY MANUALLY TWISTING THE MYOSURE DEVICE'S DRIVE CABLE (THE CUTTER BLADE WAS NOT JAMMED), AT WHICH POINT THE ESSURE DEVICE FELL OUT. THE MYOSURE DEVICE WAS PLUGGED INTO A CONTROL BOX AND RAN NORMALLY. A SMALLER PART OF THE ESSURE DEVICE WAS THEN INSERTED INTO THE MYOSURE DEVICE'S CUTTING WINDOW DURING OPERATION. THE CUTTER DID NOT JAM, AND CUT THROUGH THE ESSURE DEVICE AFTER SEVERAL (~5) SECONDS).

    Description of Event or Problem · 1

    THE MYOSURE DEVICE WAS USED TO RESECT A 2CM SUBMUCOSAL FIBROID LOCATED IN THE LEFT LATERAL FUNDUS OF THE UTERUS WHICH WAS ADJACENT TO A RECENTLY PLACED ESSURE IMPLANT (CONCEPTUS). DURING TISSUE RESECTION, PART OF THE ESSURE IMPLANT WAS SUCKED INTO THE CUTTING WINDOW OF THE MYOSURE DEVICE WHERE IT BECAME TANGLED WITH CUTTING BLADE. THE MYOSURE DEVICE AND ESSURE IMPLANT WERE REMOVED TOGETHER WITH NO INJURY OR CLINICAL SEQUELA TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MYOSURE TISSUE REMOVAL DEVICE HYSTEROSCOPE AND ACCESSORIES HIH INTERLACE MEDICAL, INC. NA 091116-1

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other