BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS STAPLER

    MDR report key: 3936003 · Received July 15, 2014

    Report

    Report Number
    3005075853-2014-04974
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 7, 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
    EZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT THE CDH33 DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: DID THE DEVICE CUT? IF THE DEVICE CUT, WAS THE CUT LINE FULLY CIRCUMFERENTIAL AROUND THE TARGET TISSUE? DID THE SURGEON REPORT ANY DIFFERENCES IN THE WAY THE DEVICE FIRED? WHAT CONFIRMATION WAS RECEIVED THAT THE DEVICE WAS FULLY FIRE? WAS THE DEVICE DIFFICULT TO FIRE? WHERE WITHIN THE GREEN GAP/COMPRESSION SCALE WAS THE ORANGE INDICATOR SET FOR FIRING?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RECTUM PROCEDURE, THERE WAS NO ANASTOMOSIS AFTER FIRING THE STAPLER. THE STAPLES WERE NOT FOUND IN THE PATIENT OR OUTSIDE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413437 PROXIMATE ILS STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1