BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 3591730 · Received January 24, 2014

    Report

    Report Number
    3005075853-2014-00663
    Event Type
    Malfunction
    Date Received
    January 24, 2014
    Date of Event
    January 11, 2014
    Report Date
    January 13, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT ONE LONG60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    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. WERE THE FIRING STROKES COMPLETED? DID THE DEVICE DELIVER A COMPLETE STAPLE LINE (NO STAPLES WERE MISSING ALONG THE CUT LINE) EVEN THOUGH SOME STAPLES WERE UNFORMED? DID THE DEVICE DELIVER A COMPLETE CUT LINE? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROBOTIC ROUX EN Y GASTRIC BYPASS PROCEDURE, ON THIRD OR FOURTH FIRING OF DEVICE, CREATING GASTRIC POUCH, STAPLE LINE APPEARED DISTORTED, INCONSISTENT WITH PREVIOUS FIRINGS. PICTURE REVEALED UNFORMED STAPLE WIRE AT DISTAL END, CROTCH, OF STAPLE LINE. SURGEON ALSO COMMENTED THAT STAPLER SEEMED TO "JAM" AT CONCLUSION OF FIRING (NFI). NEW DEVICE OPENED TO COMPLETE THE STOMACH POUCH AND CREATE JEJUNOJEJUNOSTOMY. AIR LEAK TEST PERFORMED WITH NO INDICATION OF STAPLE LINE COMPROMISE ALONG POUCH OR GASTROJEJUNOSTOMY. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56552 ECHELON*FLEX60 LONG STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60B