BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON ENDO-SURGERY, LLC LINEAR CUTTER FOR USE WITH SELECTABLE RELOAD, 75 MM

    MDR report key: 8469446 · Received April 1, 2019

    Report

    Report Number
    3005075853-2019-17700
    Event Type
    Injury
    Date Received
    April 1, 2019
    Date of Event
    February 6, 2019
    Report Date
    March 6, 2019
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036002628
    PMA / PMN Number
    K092577
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). BATCH # UNK. THE LOT/BATCH WAS NOT PROVIDED; THEREFORE, A MANUFACTURING RECORD EVALUATION COULD NOT BE PERFORMED. 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 WERE THE INDICATIONS FOR SURGERY? WHAT SPECIFIC TYPE OF COLECTOMY WAS BEING PERFORMED? WHAT COLOR SETTING WAS USED FOR EACH OF THE FOUR FIRINGS? WHICH ANASTOMOTIC STAPLE LINE WAS THE FOURTH FIRING (JOINING THE COLON SEGMENTS, CLOSING THE COMMON OPENING, ETC.)? WHICH PORTION OF THE ANASTOMOSIS WAS OVERSEWN? WAS A LEAK TEST PERFORMED? IF SO, WHAT WAS THE RESULT? HOW WAS LEAK IDENTIFIED? WAS THE LEAK CONFIRMED TO BE FROM THE STAPLE LINE OF THE FOURTH FIRING? IF NOT, WHERE? WHAT WAS OBSERVED AT THE SITE OF THE LEAK UPON REOPERATION? WAS ANY TISSUE ISCHEMIA OBSERVED? WERE THERE ANY ISSUES NOTED WITH STAPLE FORMATION? HOW WAS THE LEAK ADDRESSED? WERE THERE OTHER CONTRIBUTING FACTORS TO THE LEAK TO INCLUDE PATIENT TISSUE CONDITION? WHAT IS THE CURRENT STATUS OF THE PATIENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGEON HAS A PATIENT WITH A LEAK FROM A SURGERY THAT OCCURRED (B)(6) 2019. THE SURGEON REPORTED THAT ON A LAP ASSISTED COLECTOMY HE FIRED THE NTLC75 FOUR TIMES AND ON THE FOURTH FIRE HE FELT LIKE THE STAPLER DID NOT CUT ALL THE WAY BUT THERE WERE WELL FORMED STAPLES PRESENT. HE REPORTED THAT HE INSPECTED THE STAPLE LINE AND IT LOOKED GOOD AND HE OVER SEWED THE ANASTOMOSIS AT THE TIME OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262020 ETHICON ENDO-SURGERY, LLC LINEAR CUTTER FOR USE WITH SELECTABLE RELOAD, 75 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. 10705036002628

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RELOAD - SR75