BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM

    MDR report key: 3251791 · Received July 18, 2013

    Report

    Report Number
    1222780-2013-00133
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 18, 2013
    Manufacturer
    HOLOGIC
    Product Code
    HIH
    PMA / PMN Number
    K100559
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE LOT WAS RELEASED MEETING ALL QA SPECIFICATIONS. CURRENTLY UNABLE TO ESTABLISH A RELATIONSHIP OR IMPACT TO THE REPORTED OBSERVATION. 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. MYOSURE DISPOSABLE: 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, DURING A MYOSURE PROCEDURE FOR UTERINE TISSUE REMOVAL, THE FIRST DISPOSABLE DEVICE USED WAS UNSUCCESSFUL. THE PHYSICIAN THEN USED A SECOND DISPOSABLE DEVICE AND THE FLUID DEFICIT STARTED TO RISE (AMOUNT UNKNOWN). A LAPAROSCOPY WAS PERFORMED AND DID NOT REVEAL A PERFORATION. THE PHYSICIAN CONTINUED THE PROCEDURE AND THE FLUID DEFICIT WENT UP TO "1200ML." ANOTHER LAPAROSCOPY WAS PERFORMED AND DID NOT REVEAL A PERFORATION. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2013, IT WAS REPORTED "THE PATIENT RETURNED TO THE HOSPITAL ON (B)(6) 2013 AND WAS FOUND TO BE SEPTIC AND THERE WAS NICK ON THE PATIENT'S BOWEL." THE PHYSICIAN "REPAIRED" THE PATIENT'S RECTUM AND THE PERFORATION. THE PATIENT IS IN THE INTENSIVE CARE UNIT (ICU) WITH A COLOSTOMY BAG, INTUBATED AND RECEIVING "STRONG ANTIBIOTICS." ON (B)(6) 2013, IT WAS REPORTED, A PERFORATION WAS NOTED ON THE BOWEL AND THE UTERUS. IT IS UNKNOWN IF INTERVENTION WAS REQUIRED FOR THE UTERINE PERFORATION. ADDITIONALLY, IT WAS REPORTED "THE COLOSTOMY IS GOING TO BE REVERSED AROUND 3 MONTHS FROM DISCHARGE." IT IS UNKNOWN IF THE PATIENT HAS BEEN DISCHARGED. WE HAVE BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION SURROUNDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333936 MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM HIH HOLOGIC NA 13C19R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R SALINE DISTENTION MEDIA| MYSORE HYSTEROSCOPE - SERIAL # UNK| MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM,| CONTROL UNIT - SERIAL # UNK