BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP

    MDR report key: 12985183 · Received December 13, 2021

    Report

    Report Number
    3005075853-2021-07637
    Event Type
    Injury
    Date Received
    December 13, 2021
    Date of Event
    November 10, 2021
    Report Date
    December 13, 2021
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014584
    PMA / PMN Number
    K141952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. 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 WAS THE PROCEDURE? WHAT WERE THE VEINS CONDITIONS OF THE VEINS? ANY CALCIFICATION OF TISSUE THAT COULD IMPEDE CLAMPING, CUTTING OR FIRING? ANY PREEXISTING CONDITIONS THAT CONTRIBUTE TO EVENT? HOW WAS THE POST-OP BLEEDING IDENTIFIED? HOW MANY DAYS POSTOPERATIVE WAS THE BLEEDING IDENTIFIED? WHAT WAS THE TOTAL ESTIMATED BLOOD LOSS (ML)? WAS A TRANSFUSION REQUIRED? WHAT WAS THE PRE AND POSTOPERATIVE ANTI-COAGULANT AND PAIN MANAGEMENT PROTOCOL? WAS THE BLEEDING INTRALUMINAL OR EXTRALUMINAL? ANY UNUSUAL NOISES DURING THE FIRE CYCLE? APPROXIMATELY HOW FAR DID THE DEVICE CUT AND/OR STAPLE? HOW WAS THE KNIFE RETURNED HOME? ANY VIDEOS AVAILABLE?

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH # UNK. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AS PART OF ETHICON'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THE MANUFACTURING RECORDS WERE REVIEWED AND THE MANUFACTURING/PACKAGING CRITERIA WERE MET PRIOR TO THE RELEASE OF THIS BATCH. 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 WAS THE PROCEDURE? WHAT WERE THE VEINS CONDITIONS OF THE VEINS? ANY CALCIFICATION OF TISSUE THAT COULD IMPEDE CLAMPING, CUTTING OR FIRING? ANY PREEXISTING CONDITIONS THAT CONTRIBUTE TO EVENT? HOW WAS THE POST-OP BLEEDING IDENTIFIED? HOW MANY DAYS POSTOPERATIVE WAS THE BLEEDING IDENTIFIED? WHAT WAS THE TOTAL ESTIMATED BLOOD LOSS (ML)? WAS A TRANSFUSION REQUIRED? WHAT WAS THE PRE AND POSTOPERATIVE ANTI-COAGULANT AND PAIN MANAGEMENT PROTOCOL? WAS THE BLEEDING INTRALUMINAL OR EXTRALUMINAL? ANY UNUSUAL NOISES DURING THE FIRE CYCLE? APPROXIMATELY HOW FAR DID THE DEVICE CUT AND/OR STAPLE? HOW WAS THE KNIFE RETURNED HOME? ANY VIDEOS AVAILABLE?

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VIDEO-ASSISTED UPPER LOBECTOMY ON THE RIGHT, THE UPPER LOBE VEIN, THE PRODUCT DID NOT FIRE COMPLETELY. (ONLY HALF OF THE VEIN WAS CLAMPED AND CUT, THE MOVEMENT CYCLE OF THE INSTRUMENT DID NOT REACH THE END OF THE MAGAZINE). THE SAME PROBLEM ALSO EXISTED WITH 2 OTHER MAGAZINES. AS A RESULT, THERE WAS MORE BLEEDING, SO THAT AN EMERGENCY THE PATIENT HAD TO BE CONVERTED TO AN OPEN PROCEDURE AS AN EMERGENCY. THE PATIENT LOST ABOUT 2 LITERS OF BLOOD AS A RESULT. THE PATIENT YEAR OB (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A VIDEO-ASSISTED UPPER LOBECTOMY ON THE RIGHT, THE UPPER LOBE VEIN, THE PRODUCT DID NOT FIRE COMPLETELY. (ONLY HALF OF THE VEIN WAS CLAMPED AND CUT, THE MOVEMENT CYCLE OF THE INSTRUMENT DID NOT REACH THE END OF THE MAGAZINE). THE SAME PROBLEM ALSO EXISTED WITH 2 OTHER MAGAZINES. AS A RESULT, THERE WAS MORE BLEEDING, SO THAT AN EMERGENCY THE PATIENT HAD TO BE CONVERTED TO AN OPEN PROCEDURE AS AN EMERGENCY. THE PATIENT LOST ABOUT 2 LITERS OF BLOOD AS A RESULT. THE PATIENT YEAR OB (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886043 ECHELON FLEX POWERED VASCULAR STAPLER WITH ADVANCED PLACEMENT TIP STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PVE35A V95400 10705036014584

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention VASECR35 (X3)