BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILS 29MM, CURVED

    MDR report key: 2871157 · Received December 12, 2012

    Report

    Report Number
    3005075853-2012-05658
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    November 14, 2012
    Report Date
    December 6, 2012
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RECTUM PROCEDURE, THE DEVICE WOULD NOT STAPLE. DURING A LATERO-TERMINAL ANASTOMOSIS OF THE RECTUM, THE FIRING COULD NOT BE COMPLETE. THERE WERE NOT ANY UNEXPECTED NOISES OR FORCES. THE DEVICE DID NOT STAPLE BUT WHEN THE SURGEON MOVED THE DEVICE, THE STAPLE LINE PERFORATED THE RECTUM. AFTER SUTURING OF THE PERFORATION, THE SAME DEVICE WAS USED TO PERFORM THE ANASTOMOSIS WITHOUT ANY ISSUE. THE DEVICE WAS THEN DISCARDED. THE PATIENT HAS SUFFERED FROM A FISTULA WHICH REQUIRED TWO REOPERATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NO RESPONSE HAS BEEN RECEIVED TO DATE, A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ILS 29MM, CURVED STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK J4ACC72

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention