BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3974036 · Received August 1, 2014

    Report

    Report Number
    3005075853-2014-05438
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE ANALYSIS RESULTS FOUND THAT ONE PSE60A DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITHOUT RELOAD PRESENT. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BENT AND FOR THE FIRING STROKE AND THE STAPLE FORM TO BE INCOMPLETE. NO FURTHER FUNCTIONAL COULD BE PERFORMED DUE TO THE CONDITION OF THE ANVIL, HOWEVER THE DEVICE WAS DRY FIRED TO TEST THE CONDITION OF THE FIRING MECHANISM AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE FOUND CONDITION OF THE ANVIL MAY LEAD THAT THE MOST DISTAL STAPLES NOT TO FORM PROPERLY. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT (B)(4).

    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. ADDITIONAL INFORMATION OBTAINED: THE EVENT WAS WITH A BLACK CARTRIDGE. IT WAS ON THE SECOND FIRING. THERE WAS BUTTRESS ON BOTH THE ANVIL AND CARTRIDGE JAW OF THE DEVICE. THERE WERE STAPLES FORMED ON THE SPECIMEN SIDE OF THE STOMACH BUT NONE OF THE REMNANT SIDE OF THE STOMACH. SURGEON DID REPORT THE STAPLER SEEMED TO ¿STRUGGLE¿ WHEN FIRING, WAS WITH A POWERED DEVICE. THE ISSUE IS WITH THE RELOAD, NOT THE GUN. SURGEON SUTURE CLOSED THE STOMACH AND PATIENT HAS NOW GONE HOME. DELAY WAS 10 MINUTES WHILST STOMACH WAS SUTURED CLOSED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS THERE ANY PATIENT CONSEQUENCE OR CHANGE IN THE POST-OPERATIVE CARE FOR THE PATIENT AS A RESULT OF THE EVENT? THERE WAS NOT. PATIENT WENT HOME AS PER USUAL PROTOCOL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE SURGEON HAD AN ISSUE WITH THE DEVICE NOT STAPLING. THE SURGEON SAID ¿THIS STAPLER WOULD NOT STAPLE BOWEL CORRECTLY. STAPLES WOULD NOT CLOSE AFTER CUTTING. THE BOWEL REMAINED CUT BUT OPEN WITH LOOSE STAPLES¿. A SECOND DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE EVENTS TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450725 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EG50

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD: ECR60T