BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 10MM

    MDR report key: 3961266 · Received May 28, 2014

    Report

    Report Number
    2647580-2014-00394
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 29, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF INITIAL REPORT SENT: 05/28/2014.

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAP HERNIA REPAIR. ACCORDING TO THE REPORTER: THE EVENT IS REPORTED AS FOLLOWS: AS (B)(6) WAS REMOVING THE GREY INSIDE OR PORT KEPT POPPING OUT. DID THE DIFFICULTY RESULT IN UNINTENDED COLOSTOMY, FORMAL LAPAROTOMY, RE-OPERATION: NO. DID THIS DEVICE PROBLEM DIRECTLY RESULT IN ANY OF THE FOLLOWING: UNANTICIPATED TISSUE LOSS.: NO. WAS THERE IRREVERSIBLE TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. NO. UNANTICIPATED EXTENSION OF THE INCISION BY MORE THAN 1 INCH: NO. UNANTICIPATED BLOOD LOSS OF 500CC OR MORE: NO. WAS SURGICAL TIME DELAYED BY MORE THAN 30 MINUTES DUE TO THE PRODUCT PROBLEM: NO. DEVICE FRAGMENT OR COMPONENTS FALLING INTO THE PT'S CAVITY: NO. DEVICE FRAGMENT LEFT IN THE PT: NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313063 SPACEMAKER BLUNT TIP TROCAR 10MM SPACEMAKER BALLOON GCJ COVIDIEN, FORMERLY USSC PUERTO RICO P3M0286X

    Patients

    Seq Age Sex Outcome Treatment
    1