BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 4200771 · Received October 24, 2014

    Report

    Report Number
    3005075853-2014-07357
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 6, 2014
    Report Date
    October 6, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    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). ADDITIONAL INFORMATION: THE ANALYSIS FOUND THAT ONE ECR60G CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS AND CARTRIDGE BODY WAS NOTED TO BE DAMAGED. THE RELOAD WAS RECEIVED WITH THE RIGHT SIDE FULLY FIRED, LEFT SIDE OUTER ROW FULLY FIRED AND THE LEFT TWO INNER ROWS PARTIALLY FIRED 1/5. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, ONE PIECE SLED AND SOME DRIVERS WERE NOTED TO BE DAMAGED. NO OBVIOUS DAMAGE TO THE CARTRIDGE DECK WAS NOTED, WHICH SUGGESTS THE CARTRIDGE, MAY NOT HAVE BEEN FIRED OVER A HARD OBJECT. ADDITIONALLY THE CARTRIDGE PAN WAS FOUND DETACHED FROM THE CARTRIDGE BODY. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOAD.

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT. WHAT WAS THE PRODUCT CODE AND LOT/BATCH NUMBER FOR THE STAPLER USED WITH THE ECR60G CARTRIDGE (EX, EC60, LONG60A, PSE60A, ETC)? WILL THE STAPLER BE RETURNED FOR ANALYSIS? WHAT WAS THE PATIENT¿S BMI AND GENDER? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC SLEEVE PROCEDURE, THE SURGEON FIRED TWO BLACK CARTRIDGES; NO ISSUES. THE SURGEON FIRED ONE GREEN CARTRIDGE AND ONLY ONE STAPLE LINE FORMED ON THE PATIENT SIDE. ADDITIONAL GREEN CARTRIDGES WERE USED TO COMPLETE THE PROCEDURE. UPON AN INITIAL INSPECTION BY THE SALES REP, IT IS CLEAR THAT THE INTERIOR PIECE OF THE CARTRIDGE (WHERE THE BLADE TRAVELS) BROKE AND KNOCKED THE SLED FREE. THIS PREVENTED THE SLED FROM DRIVING THE STAPLES UP THROUGH THE TISSUE. IT IS UNCLEAR WHAT BROKE THE CARTRIDGE AND THERE IS NOTHING STUCK IN THE SPECIMEN THAT INDICATES IT WAS CLOSED ON SOMETHING HARD. ADDITIONAL GREEN CARTRIDGES WERE USED FROM THE SAME LOT NUMBER, AND THE SAME GUN WAS USED. LUCKY, AS THE SURGEON POINTS OUT, THERE WAS ENOUGH TISSUE LEFT FOR HIM TO REVISE THE STAPLE LINE FOR THIS CASE. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679948 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4F340

    Patients

    Seq Age Sex Outcome Treatment
    1