BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE CIRCULAR STAPLER

    MDR report key: 4143487 · Received October 6, 2014

    Report

    Report Number
    3005075853-2014-06842
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 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
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE CDH29A DEVICE ARRIVED AND IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND UNCUT AND THE DEVICE WAS FULLY LOADED WITH STAPLES, INDICATING THAT THE DEVICE HAD NOT BEING FIRED. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH THE RETURNED WASHER AND 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.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 INFORMATION: DID THE DEVICE CUT? YES, IF THE DEVICE CUT WAS CUT LINE FULLY CIRCUMFERENTIAL AROUND THE TARGET TISSUE? YES, DID THE DEVICE STAPLE? YES, IF THE DEVICE STAPLED, WAS THE STAPLE LINE COMPLETE? NO, ONLY THE PROXIMAL PART HAD STAPLE LINE. WHAT CONFIRMATION WAS RECEIVED THAT THE DEVICE WAS FULLY FIRED? THE OPERATOR HIMSELF ASSERTED THAT HE FULLY FIRED THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE FIRING WAS NOT COMPLETED THAT THE OPERATOR HAD TO SUTURE AGAIN. NO PATIENT CONSEQUENCES RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623224 PROXIMATE CIRCULAR STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4DF2E

    Patients

    Seq Age Sex Outcome Treatment
    1