BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE CIRCULAR STAPLER

    MDR report key: 4113030 · Received September 24, 2014

    Report

    Report Number
    3005075853-2014-06633
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K940967
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE ECS29A DEVICE ARRIVED WITH THE ANVIL MISSING, OTHERWISE IN GOOD VISUAL CONDITION. AS THE ORIGINAL ANVIL WAS NOT RECEIVED, FURTHER INVESTIGATION WITH THE ORIGINAL ANVIL COULD NOT BE PERFORMED. THE BREAKAWAY WASHER WAS NOT PRESENT AND THERE WERE NO STAPLES PRESENT. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY WITH A TEST ANVIL; IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. IT SHOULD BE NOTED THAT WHEN REMOVING THE DEVICE; OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS. TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION NEEDED. A BATCH RECORD REVIEW WAS PERFORMED AND THE BATCH HAD NO ANOMALIES NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLON PROCEDURE, WHEN TRYING TO REMOVE AFTER THE ANASTOMOSIS, THE DEVICE WOULD NOT DISENGAGE. THE USER HAD TO RESECT THE ANASTOMOSIS FOR REMOVAL. THE AREA WAS OVER SEWED TO COMPLETE THE PROCEDURE. A LEAK WAS DETECTED AND THE AREA WAS OVER SEWED AGAIN TO MANAGE THE LEAK. THERE WAS NO PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593241 PROXIMATE CIRCULAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EY0J

    Patients

    Seq Age Sex Outcome Treatment
    1