BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO¿

    MDR report key: 2436841 · Received February 2, 2012

    Report

    Report Number
    3005099803-2012-00351
    Event Type
    Malfunction
    Date Received
    February 2, 2012
    Date of Event
    January 11, 2012
    Report Date
    January 11, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WAS BEING PREPARED FOR AN ANTERIOR REPAIR PROCEDURE. THE PATIENT AGE WAS REPORTED TO BE OVER 18 YEARS.ACCORDING TO THE COMPLAINANT, A HOLE ABOUT THE SIZE OF THE CAPIO HEAD WAS NOTICED IN THE INNER PACKAGE OF THE DEVICE AFTER IT WAS OPENED. THE HOLE WAS LOCATED WHERE THE CAPIO HEAD WAS INSIDE THE POUCH. THERE WAS NO DAMAGE TO THE OUTSIDE PACKAGING AND THE STERILE SEAL AROUND THE PACKAGE DID NOT APPEAR COMPROMISED. THIS DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER CAPIO DEVICE. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GREAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO¿ LAPAROSCOPE, GENERAL & PLASTIC SURGERY FHQ BOSTON SCIENTIFIC - MIAMI M0068311251 11808061

    Patients

    Seq Age Sex Outcome Treatment
    1