BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER BLUNT TIP TROCAR 12MM

    MDR report key: 4231546 · Received November 6, 2014

    Report

    Report Number
    2647580-2014-00951
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 20, 2014
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K924011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    PROCEDURE: NEPHRECTOMY. ACCORDING TO THE REPORTER: DURING USE THE BALLOON COULD BE INFLATED BUT IT COULD NOT BE FIXED TO THE PATIENT. UPON INJECTING SOME WATER IN IT TO FIX IT, IT WAS FOUND THAT THE BALLOON WAS TORN. NEW ONE WAS OPENED TO COMPLETE THE CASE WITH NO PROBLEM. NO PATIENT HARM. THE PATIENT CURRENT STATUS: GOOD OPERATING TIME WAS NOT EXTENDED. TISSUE DAMAGE: NO. NOTHING FELL INTO THE CAVITY. NO BLEEDING. CONFIRMED THAT THE CLINICAL SAMPLE IS BEING RETURNED FOR INVESTIGATIONS. WHEN IT IS RETURNED TO THE INVESTIGATOR OF MANUFACTURER : UNKNOWN NOTHING OF ADVERSE EVENT CAUSED BY EXTENSION OF OR TIME WAS REPORTED. "NO PATIENT INFO IS AVAILABLE: GENDER: UNKNOWN, AGE: UNKNOWN, WEIGHT: UNKNOWN / THE CUSTOMER DID NOT KNOW IF REINFORCEMENT MATERIAL WAS USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713792 SPACEMAKER BLUNT TIP TROCAR 12MM ACCESS DEVICE GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC OMST12BT P2J0018X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other