BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 3230019 · Received July 12, 2013

    Report

    Report Number
    1222780-2013-00131
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 14, 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. 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. MYOSURE HYSTEROSCOPE: ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WARNINGS: UTERINE PERFORATION CAN RESULT IN POSSIBLE INJURY TO BOWEL, BLADDER, MAJOR BLOOD VESSELS, AND URETER. PRECAUTIONS: TO AVOID PERFORATION, DO NOT USE THE SCOPE TIP AS A PROBE AND EXERCISE CAUTION WHEN THE SCOPE IS BEING INSERTED THROUGH THE CERVIX AND WHEN THE SCOPE TIP IS NEAR THE UTERINE WALL. MYOSURE DISPOSABLE DEVICE ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WARNINGS: TO AVOID PERFORATION, KEEP THE DEVICE TIP UNDER DIRECT VISUALIZATION AND EXERCISE CARE AT ALL TIMES WHEN MANEUVERING IT OR CUTTING IT CLOSE TO THE UTERINE WALL. NEVER USE THE DEVICE TIP AS A PROBE OR DISSECTING TOOL. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, PRIOR TO A MYOSURE PROCEDURE FOR UTERINE TISSUE REMOVAL, THE PHYSICIAN PERFORMED A SOUNDING (NOT A HOLOGIC DEVICE) AND A HYSTEROSCOPY. "ACCORDING TO THE PHYSICIAN THERE WAS A PERFORATION AT SOME POINT DURING THE PROCEDURE OF THE LOWER UTERINE SEGMENT CAUSING A RIGHT LATERAL TEAR OF A UTERINE VESSEL CAUSING A LARGE AMOUNT OF BLEEDING RESULTING IN COAGULOPATHY." THERE WAS NO PERFORATION TOWARDS THE ILEUM (SMALL BOWEL). THE PHYSICIAN KEPT THE PATIENT IN THE OPERATION ROOM (OR) FOR "4 HOURS TO OBSERVE THE COAGULOPATHY." AT THIS POINT, THE PHYSICIAN NOTICED BLOOD IN THE PATIENT'S URINE AND DECIDED TO PERFORM EXPLORATORY SURGERY TO RECTIFY THE PROBLEM. THERE WAS NO BLADDER OR URETER DAMAGE. ON (B)(6) 2013, IT WAS REPORTED THE PATIENT WAS ADMITTED ON (B)(6) 2013 AND DISCHARGED ON (B)(6) 2013. ON (B)(6) 2013, IT WAS REPORTED BY THE PHYSICIAN THAT HE PERFORMED A HYSTERECTOMY AND THE PATIENT IS "DOING FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322087 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HIH HOLOGIC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R MYOSURE HYSTEROSCOPE: SN UNK| CONTROL UNIT: SN UNK| SALINE DISTENTION MEDIA| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM