BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 4143694 · Received October 6, 2014

    Report

    Report Number
    3005075853-2014-06854
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. IF THE DEVICE IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE CDH29 DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE ANVIL HALF WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. 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. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION, AN UNFORMED STAPLE WAS FOUND AFTER THE DEVICE WAS REMOVED FROM THE PATIENT. THE DEVICE WAS USED TO ANASTOMOSE BETWEEN THE COLON AND THE RECTUM. THERE WAS NO DIFFICULTY IN FIRING AND REMOVING THE DEVICE. THE FIRING HANDLE WAS FULLY GRASPED AND THE SOUND OF CUTTING WASHER WAS HEARD. THE TARGET TISSUE WAS CUT PROPERLY AND DONUTS WERE FORMED COMPLETELY. THE TARGET TISSUE HAD BEEN RESECTED WITH A SC40G PRIOR TO USING THE CDH29. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624055 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1