BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DILATING TIP TROCAR WITH STABILITY SLEEVE - 5MM DIAMETER

    MDR report key: 1231174 · Received November 10, 2008

    Report

    Report Number
    1527736-2008-03986
    Event Type
    Malfunction
    Date Received
    November 10, 2008
    Date of Event
    December 15, 2006
    Report Date
    November 6, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, INC. (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K952842
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 11/10/2008. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE REDUCTOR PRESENTED LEAKING. NO FURTHER INFO WAS OR WILL BE PROVIDED. NO SAMPLE WILL BE RETURNED. UNKNOWN HOW CASE WILL BE COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DILATING TIP TROCAR WITH STABILITY SLEEVE - 5MM DIAMETER GCJ ETHICON ENDO-SURGERY, INC. (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1