BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO SUTURE CAPTURING DEVICE

    MDR report key: 249784 · Received November 16, 1999

    Report

    Report Number
    1051710-1999-00012
    Event Type
    Malfunction
    Date Received
    November 16, 1999
    Date of Event
    September 17, 1999
    Report Date
    October 23, 1999
    Manufacturer
    MICROVASIVE UROLOGY A DIV. OF BOSTON SCIENTIFIC CORP.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CARRIER WAS GETTING STUCK. ADDITIONAL INFORMATION OBTAINED FROM FOLLOW UP ON 10/22/1999. DETERMINED THE CARRIER WOULD NOT RETRACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO SUTURE CAPTURING DEVICE SUTURING DEVICE GCJ MICROVASIVE UROLOGY A DIV. OF BOSTON SCIENTIFIC CORP. NA 2414121

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other