BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON LINEAR CUTTER

    MDR report key: 3911316 · Received July 3, 2014

    Report

    Report Number
    3005075853-2014-04628
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. 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 AND OBTAINED. WHAT STRUCTURE WERE THEY ON WHEN THE ISSUE OCCURRED? FIRST FIRING OF STOMACH. SURGEON FIRES ACROSS VESSELS OF LESSER CURVATURE WITH WHITE LOAD FIRST. THEN GREEN LOAD IS THE FIRST FIRING ON THE STOMACH. WHICH FIRING DID IT OCCUR ON? SECOND FIRING OF STAPLER WHAT IS MEANT BY COULD NOT STOP IT? STAPLER CONTINUED TO FIRE BUNCHING IN TISSUE. COULD THEY NOT STOP THE BLADE FROM ADVANCING OR COULD THEY NOT STOP THE TISSUE FROM BUNCHING? STOP THE TISSUE FROM BUNCHING AND PULLING TISSUE IN WHEN FIRING. DID THE SURGEON NOT COMPLETE THE FIRING STROKE OR DID HE INTERRUPT THE STROKE? UNKNOWN, DON'T BELIEVE SO WAS A STAPLE LINE BEING CROSSED AT THE TIME OF THIS EVENT? SECOND FIRING IN A ROW. WHAT DID THE STAPLE FORM LOOK LIKE? UNFORMED STAPLES . HOW DID THEY MANAGE THE LEAK POST-OP? SURGEON OVERSEWED WHAT HE COULD. PATIENTS ROUX LIMB LEAKED POST OP, CLOTTED. PATIENT STILL IN HOSPITAL, GOING ON 4TH WEEK. WHERE WAS THE HOLE ON THE STAPLE LINE? UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE THE STAPLER BUNCHED TISSUE UP DURING FIRING OF GREEN LOAD ON THE STOMACH. THERE WAS A HOLE IN THE STAPLER LINE AFTER THE DEVICE WAS FIRED. SURGEON REPAIRED THE HOLE INTRA-OP. PATIENT LEAKED AGAIN ON POST-OP DAY 3 AND PATIENT WAS BROUGHT BACK TO THE OR. "IT WAS LIKE THE STAPLER DIDN'T FIRE SMOOTHLY AND JUST PULLED THE TISSUE IN A LUMP AND FIRED AND HE COULDN'T STOP IT" REPORTED THE SURGICAL ASSIST. REPAIRED LEAK INTRA-OP WITH SUTURE. DEVICE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389343 ECHELON LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD - ECR60G