BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVE CUTTER STAPLER

    MDR report key: 2240675 · Received September 9, 2011

    Report

    Report Number
    3005075853-2011-03709
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 19, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT.INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    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 AUTOMATED VISION SYSTEM, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLORECTAL RESECTION PROCEDURE, THE DEVICE WOULD NOT STAPLE BUT CUT. THE DEVICE CUT WELL BUT DID NOT STAPLE. THE DEVICE WAS USED ON A COLON. THE CARTRIDGE USED WAS THE FIRST ONE AND IT WAS A BLUE ONE. THE DEVICE WAS NOT FIRED NEXT TO AN EXISTING STAPLE LINE. NO RESISTANCE WAS FELT BY THE SURGEON. AFTER USE ALL BUTTONS AND TRIGGERS AUTOMATICALLY RETURNED TO THEIR ORIGINAL POSITION. THE SURGEON DID NOT HAVE ANY DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT TISSUE. THE SURGEON HAD TO DO A MANUAL SUTURE TO FINISH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVE CUTTER STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TX60

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE