BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP

    MDR report key: 9677284 · Received February 6, 2020

    Report

    Report Number
    3005075853-2020-00814
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    January 5, 2020
    Report Date
    January 14, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014584
    PMA / PMN Number
    K141952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). BATCH # UNK. WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCE. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS THE INDICATION FOR SURGERY PERFORATED APPENDICITIS OR SIMPLE APPENDICITIS? DNK. HOW MANY FIRINGS OF PVS WERE REQUIRED TO COMPLETE APPENDECTOMY? 3 FIRINGS. WAS THE PVS USED ON BOTH MESO APPENDIX AND APPENDICULAR STUMP? YES. WAS A WINDOW CREATED IN MESO APPENDIX FOR TIP TO BE VISIBLE? YES. CAN IF BE CONFIRMED THAT ENTIRE WIDTH OF TISSUE BEING TRANSECTED WAS PROXIMAL TO CUT LINE AND NO EXTRANEOUS TISSUE WAS WITHIN JAWS DISTAL TO CUT LINE? DNK. DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? DNK. WHAT WAS THE SIGHT OF THE BLEEDING? MESOAPPEDIX. WHAT IS THE CURRENT PATIENT STATUS? PATIENT IS DOING FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR PERFORMED A LAPAROSCOPIC APPENDECTOMY ON A PATIENT AND THE PATIENT WAS BLEEDING ON THE STAPLE LINE AND NEEDED TO GO BACK TO SURGERY. IT WAS NOT REPORTED WHAT WAS DONE TO RESOLVE THE BLEEDING OR THE OUTCOME OF THE SURGERY. THIS IS ALL THE INFORMATION KNOWN/AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141089 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PVE35A 10705036014584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention