BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12X100MM KII BALLOON BLUNT TIP SYSTEM

    MDR report key: 2851014 · Received November 16, 2012

    Report

    Report Number
    2027111-2012-00362
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    October 19, 2012
    Report Date
    November 16, 2012
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADD'L INFO, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.

    Description of Event or Problem · 1

    LAPAROSCOPIC LOW ANTERIOR RESECTION: "THIS IS THE COMPLAINT FROM THE MARKET. DURING OPERATION, THE CUSTOMER NOTICED THAT A SHIELD WAS FALLING OF FROM THE INSTRUMENT. IT WAS CORRECTED. THE CUSTOMER INSERTED THE SCOPE INTO THE INSTRUMENT. MOREOVER, THE CUSTOMER TOOK GAUZE IN AND OUT OF THE INSTRUMENT TO TAKE DIRT." PT STATUS: "THE PT WAS NOT INJURED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12X100MM KII BALLOON BLUNT TIP SYSTEM NONE GCJ APPLIED MEDICAL C0R47 1173054

    Patients

    Seq Age Sex Outcome Treatment
    1 SCOPE (MODEL NAME IS UNK)