BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS LINEAR CUTTER

    MDR report key: 3926419 · Received July 10, 2014

    Report

    Report Number
    3005075853-2014-04793
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 26, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHAT WAS THE APPEARANCE OF THE STAPLES (B-SHAPED, IRREGULAR)? WERE THERE ANY STAPLES MISSING FROM THE STAPLE LINE?

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: BATCH # L51P4D; MFG. 02/25/2014; EXP. 1/25/2019. THE ANALYSIS RESULTS FOUND THAT FOUR 6R45B RELOADS WERE RECEIVED IN GOOD VISUAL CONDITION. CARTRIDGES (A, B) 6R45B, L52026 WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITIONS. CARTRIDGES (C, D) 6R45B, L51P4D, WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITIONS. NO FURTHER FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOADS. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTROPLASTY BY VIDEO PROCEDURE, BLUE CHARGER NOT PROPERLY CLOSED STAPLING. THEREFORE, REQUIRING SUTURE LINE IN ALL THE STAPLING. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404959 ETS LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EA9K

    Patients

    Seq Age Sex Outcome Treatment
    1