BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM

    MDR report key: 2063279 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01209
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PRODUCT HAS BEEN RETURNED, THE DEVICE HAS NOT YET BEEN EVALUATED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THE DEVICE AND THE CAUSE OF THIS EVENT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE HTA PROCEDURE SET WAS RETURNED AND EVALUATED. THE COMPLAINT INVESTIGATION REVEALED A HAIR WAS FOUND INSIDE THE MOLDED TRAY THAT HOLDS THE SHEATH. THE ROOT CAUSE CLASSIFICATION FOR THIS EVENT IS SUPPLIER MANUFACTURE, BASED ON THE RETURNED CONDITION OF THE PRODUCT.

    Description of Event or Problem · 1

    A GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS REPORTED THAT A HAIR WAS FOUND IN THE STERILE COMPARTMENT. ADDITIONAL FOLLOW UP EVENT INFORMATION REPORTED THAT THE HAIR WAS LOCATED ON THE STERILE PIECE ON THE WHITE TRAY. THE STERILE PIECE THAT IS HANDED TO THE PHYSICIAN. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT. THE PATIENT WAS REPORTED TO BE "FINE."

    Description of Event or Problem · 1

    A GENESYS HYDROTHERMABLATION PROCERVA PROCEDURE SET WAS USED DURING A HYDROTHERMABLATION (HTA) PROCEDURE PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, IT WAS REPORTED THAT A HAIR WAS FOUND IN THE STERILE COMPARTMENT. ADDITIONAL FOLLOW UP EVENT INFORMATION REPORTED THAT THE HAIR WAS LOCATED ON THE STERILE PIECE ON THE WHITE TRAY. THE STERILE PIECE THAT IS HANDED TO THE PHYSICIAN. THERE WERE NO FURTHER COMPLICATIONS REPORTED WITH THIS EVENT. THE PATIENT WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDRO THERMABLATOR (HTA) ENDOMETRIAL ABLATION SYSTEM DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006580211 40489

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR