BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEX 60 ARTICULATING

    MDR report key: 10729169 · Received October 23, 2020

    Report

    Report Number
    3005075853-2020-05531
    Event Type
    Death
    Date Received
    October 23, 2020
    Date of Event
    September 29, 2020
    Report Date
    September 29, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036001706
    PMA / PMN Number
    K081146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DATE SENT: (B)(6) 2020. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. DO YOU CONSIDER THAT THE PNEUMOTHORAX IS RELATED TO THE FAILURE OF PRODUCTS (ECR60G AND EC60A) OR IS IT RELATED TO THE EXISTING EVOLUTION? WE CANNOT ANSWER THESE QUESTIONS. PHYSICIAN DID NOT WANT TO GIVE MORE INFORMATION. 2. DO YOU CONSIDER THAT THE BILATERAL SUBCUTANEOUS EFFUSION IS RELATED TO THE FAILURE OF PRODUCTS (ECR60G AND EC60A) OR IS IT RELATED TO THE EXISTING EVOLUTION? WE CAN NOT ANSWER THESE QUESTIONS. PHYSICIAN DID NOT WANT TO GIVE MORE INFORMATION. 3. HOW LONG DOES THE SURGERY DELAY? 10 MINUTES, APPROXIMATELY. 4. IN THE PHYSICIAN¿S OPINION, COULD DELAY OF THE PROCEDURE HAVE CONTRIBUTED TO A DEATH OR A SERIOUS INJURY TO THE PATIENT? IF YES, PLEASE PROVIDE DETAILS. WE CAN NOT ANSWER THESE QUESTIONS. PHYSICIAN DID NOT WANT TO GIVE MORE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4); BATCH # UNK. AS THE DEVICE WAS NOT RETURNED, AN ANALYSIS INVESTIGATION COULD NOT BE PERFORMED. A CONCLUSION COULD NOT BE REACHED AS TO WHAT MAY HAVE CAUSED, OR CONTRIBUTED TO THE EVENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE, A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    DURING THE TREATMENT SURGERY OF EMPYEMA LOCULADO RIGHT OF PATIENT, THE SURGEON COMMENTED THAT THE REFILL DID NOT PERFORM ITS FUNCTION WHEN INTEGRATING WITH THE ECHELON STAPLER (CODE EC60A, LOT: U9358R). THE FAULT WAS IDENTIFIED DURING THE USE OF THE THIRD RECHARGE AND IT WAS SOLVED IMMEDIATELY WHEN CHANGING FOR A NEW RECHARGE OF THE SAME CODE AND SAME BATCH. THE PATIENT REMAINS HOSPITALIZED WITH A PNEUMOTHORAX IN REMISSION, A COURSE WITH BILATERAL SUBCUTANEOUS EFFUSION. EVEN WITH ENDOPLEURAL TUBE. UNFORTUNATELY, THE OUTCOME OF THE PATIENT WAS DEATH ON (B)(6) 2020. THIS CASE INVOLVES A PATIENT DIAGNOSED WITH SARS COVID-19, THE SURGICAL INTERVENTION WAS TO ATTEND TO A COMPLICATION OF IT. DURING THE USE OF THE PRODUCT, FAILURE OCCURRED AND THEY CHANGED THE STAPLER, ENDING THE SURGERY WITHOUT COMPLICATIONS FOR THE PATIENT. DURING THIS TIME, THE PATIENT REMAINED HOSPITALIZED TO CONTINUE TREATMENT FOR COVID AND WITH SEVERITY STATUS INDICATED BY HCP, UNFORTUNATELY, THE OUTCOME OF THE PATIENT WAS DEATH ON (B)(6) 2020. WE TRIED TO OBTAIN MORE INFORMATION FROM THE HCP, HOWEVER, SHE REFUSED TO PROVIDE MORE INFORMATION, SO IT WILL NOT BE POSSIBLE TO DEFINE IF THE OUTCOME OF THE PATIENT WAS MERELY DUE TO SARS COVID-19 EVOLUTION OR THE PRODUCT COULD BE RELATED. THE EMPYEMA WAS A COMPLICATION THAT THE PATIENT PRESENTED DUE TO THE COVID INFECTION. THE RELOAD DID NOT PERFORM ITS FUNCTION WHEN INTEGRATING WITH THE STAPLER. THERE WERE DIFFICULTIES IN UNLOADING THE CLIP FROM THE USE OF THE SECOND RELOAD AND DURING THE USE OF THE THIRD THE STAPLER DID NOT WORK. THE INCIDENT WAS SOLVED IN SURGERY, CHANGING FOR A NEW PIECE OF THE SAME CODE AND SAME BATCH. IT WAS CONFIRMED WITH THE TECHNICAL ASSISTANT THAT NO STAPLER CHANGE WAS MADE, ONLY RELOADS. A DELAY WAS CAUSED DURING THE MEDICAL PROCEDURE WHEN MAKING THIS CHANGE OF PIECES. THERE IS NO VISUAL EVIDENCE OF THE FAILURE DUE TO THE SECURITY PROTOCOLS IMPLEMENTED BY THE HOSPITAL, IT WAS ALSO NOT POSSIBLE TO RECOVER ANY PIECE BECAUSE IT WAS A PATIENT DIAGNOSED WITH COVID 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1191704 FLEX 60 ARTICULATING STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. EC60A U9358R 10705036001706

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death