BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON*FLEX60 LONG

    MDR report key: 2120982 · Received June 13, 2011

    Report

    Report Number
    3005075853-2011-02364
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, THE FIRST TWO FIRING WERE WITH A COVIDIEN DUET WITH A BLUE LOAD. THE SECOND TWO FIRINGS WERE WITH AN ENDOCUTTER FLEX WITH A BLUE LOAD. THERE WERE FIVE ADDITIONAL FIRING WITH THE ENDOCUTTER FLEX WITH BLUE LOAD AND PERI-STRIPS. THE SURGEON USED ENDO-STITCH TO SUTURE OVER THE TWO ENDOCUTTER FLEX FIRINGS WITHOUT PERI-STRIPS AND PART OF THE COVIDIEN DUET FIRINGS. IN ADDITION, THE SURGEON SCOPED THE PATIENT AND BLOW AIR INTO THE STOMACH PRIOR TO CLOSING AND THERE WERE NO VISIBLE LEAKS. DURING THE PROCEDURE, THE SURGEON DID NOT NOTE ANY ISSUE WITH THE DEVICE FIRING OR STAPLE FORMATION. EVERYTHING WENT GREAT. THE PROCEDURE WAS ON (B)(6), SOMETIME (B)(6) THE PATIENT DEVELOPED A LEAK. THE SURGEON WAS NOT SURE WHERE THE LEAK WAS COMING FROM. THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    DR FIRED THE COVIDIEN DEVICE AND 2 FIRES OF OURS WITHOUT PERISTRIPS. THE DOCTOR DOES USE BLUE COVIDIEN RELOADS AS A COMMON PRACTICE HE SWITCHED TO OUR STAPLER MID CASE BECAUSE HE DIDN'T LIKE THE STAPLE LINE FROM THE COVIDIEN STAPLER FOR THE FIRST TWO FIRES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention (B)(4)