BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVE CUTTER STAPLER

    MDR report key: 2180070 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03010
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K040038
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A CARTRIDGE RELOAD LOADED IN THE DEVICE. THE RELOAD WAS RECEIVED VOID OF STAPLES, WITH THE WASHER COMPLETELY CUT, WITH THE DRIVERS EXPOSED AND WITH THE KNIFE RECESS BELOW THE CARTRIDGE DECK. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH AN ENGINEERING SAMPLE RELOAD AND THE DEVICE FIRED, FORMING ALL STAPLES AND CUTTING AS INTENDED. THE CUT LINE WAS COMPLETE, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DEVICE LOCKOUT AND THE RELOAD LOCKOUT WERE FUNCTIONAL. IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4) INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, AFTER THE 1ST FIRING, IT WAS FOUND THAT STOOL LEAKED FROM THE CUT END. WHEN THE SITE WAS CHECKED, IT WAS FOUND THAT THE STAPLES OF THE ONE SIDE WERE MALFORMED. THE SITE WAS FIRED AGAIN WITH CS40B. IT WAS UNKNOWN WHETHER THE CS40B WHICH WAS USED AT THE 2ND FIRING WAS THE SAME DEVICE AS THE REPORTED DEVICE. THE OPERATION WAS FINISHED WITHOUT ANY PROBLEM. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE DOCTOR COMMENTED THAT HE HAD NOT FELT ANY DIFFICULTIES IN USING THE DEVICE. THE TARGET TISSUE WAS NOT SO THICK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE