BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTOUR CURVED CUTTER STAPLER

    MDR report key: 2100884 · Received May 24, 2011

    Report

    Report Number
    3005075853-2011-02111
    Event Type
    Injury
    Date Received
    May 24, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: LOCAL EES PERSONNEL MET WITH SURGEON. EXPLAINED MANUFACTURING PROCESSES AND DISCUSSED THE DIFFERENT GAPS FOR THE INSTRUMENT SUCH AS TOO MUCH TENSION AND GETTING THE INSTRUMENT IN THE CORRECT POSITION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED 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 DURING A LOW ANTERIOR RESECTION PROCEDURE, SURGERY WAS FINE, STAPLE LINE WAS FINE, LEAKAGE TEST O.K. THE NEXT DAY, THE STAPLE LINE DORSAL BECAME OPEN AND A RE-OPERATION WAS NECESSARY. RE-OPERATION REVEALED THAT THE STAPLES WERE NOT FORMED PROPERLY; THE ANASTOMOSIS WAS HALF RUPTURED. THE PATIENT HAS CANCER BUT THE TISSUE WAS NORMAL. NO FURTHER INFORMATION IS AVAILABLE. THE CUSTOMER DISPOSED OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTOUR CURVED CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE