BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE

    MDR report key: 6039735 · Received October 19, 2016

    Report

    Report Number
    3005099803-2016-03140
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 23, 2016
    Report Date
    September 23, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    PGT
    PMA / PMN Number
    K141848
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT WAS UNABLE TO REPORT THE LOT NUMBER; THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. HOWEVER, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT EXPIRED. MANUFACTURING SITE (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SYMPHION RESECTING DEVICE WAS USED IN THE PATIENT'S UTERUS DURING A SYMPHION UTERINE RESECTION PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ACTIVATED THE RESECTING DEVICE WHILE IN THE PATIENT'S VAGINA, LACERATING THE VAGINAL WALL. REPORTEDLY, THE PHYSICIAN THOUGHT HE WAS IN THE PATIENT'S UTERUS. THE PHYSICIAN STITCHED THE LACERATION AND CONTINUED WITH THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691458 SYMPHION¿ TISSUE REMOVAL SYSTEM RESECTING DEVICE INSUFFLATOR, HYSTEROSCOPIC, FLUID, CLOSED-LOOP RECIRCULATION WITH CUTTER-COAGULA PGT BOSTON SCIENTIFIC - MARLBOROUGH FG-0201

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention