BEUDAMED
    FDA Adverse Event Death Summary report: N

    POWERED 60 ECHELON +, 440MM SHAFT

    MDR report key: 11023163 · Received December 16, 2020

    Report

    Report Number
    3005075853-2020-06905
    Event Type
    Death
    Date Received
    December 16, 2020
    Date of Event
    November 15, 2020
    Report Date
    November 18, 2020
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    UDI-DI
    10705036014614
    PMA / PMN Number
    K110385
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 12/16/2020. 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. 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. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: DOES THE SURGEON BELIEVE THAT AN ALLEGED DEFICIENCY OF DEVICE CAUSED OR CONTRIBUTED TO THE PATIENT DEATH? NOT AT THIS TIME. IS THE CAUSE OF DEATH KNOWN? UNKNOWN. WHAT WERE THE MULTIPLE INTERVENTIONS THAT WERE PERFORMED? UNKNOWN. CAN A TIMELINE OF EVENTS BE PROVIDED? NOT AT THIS TIME. DOES THE SURGEON ROUTINELY WAIT 15 SECONDS PRIOR TO FIRING? YES. WAS BUTTRESSING MATERIAL USED? NO. WAS A LEAK TEST PERFORMED? IF SO, WHAT WAS THE RESULT? UNKNOWN BUT IT IS ROUTINE FOR THIS PARTICULAR SURGEON TO TEST THE GASTROJEJUNOSTOMY ANASTOMOSES. HOW DID THE PATIENT PRESENT? ABDOMINAL PAIN. WERE ANY ISSUES WITH STAPLE FORMATION NOTED THROUGHOUT CARE OF PATIENT? NO. WOULD THE SURGEON BE INTERESTED IN SPEAKING TO ETHICON MEDICAL AND ENGINEERING TO DISCUSS EVENT? NOT AT THIS TIME. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SLEEVE GASTRECTOMY AND 2 WEEKS POST OPERATION PRESENTED TO THE ER. AFTER MULTIPLE INTERVENTIONS, PATIENT DIED. I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484072 POWERED 60 ECHELON +, 440MM SHAFT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. PLEE60A 10705036014614

    Patients

    Seq Age Sex Outcome Treatment
    1 Death