BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1821857 · Received August 31, 2010

    Report

    Report Number
    3005075853-2010-04985
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 3, 2010
    Report Date
    August 4, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. NON-CONFORMANCES. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF A LAPAROSCOPIC SIGMOID PROCEDURE, THE PATIENT WAS TAKEN BACK TO SURGERY ON (B)(6)2010 DUE TO AN ABSCESS AND LEAKAGE. IT IS UNKNOWN HOW THE ABSCESS WAS DRAINED. DURING THE ORIGINAL PROCEDURE, THE SURGEON OVERSEWED THE STAPLE LINE AND USED EVICEL ON THE STAPLE LINE. THE DEVICE WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R