BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 5754621 · Received June 28, 2016

    Report

    Report Number
    3005075853-2016-03635
    Event Type
    Death
    Date Received
    June 28, 2016
    Report Date
    June 3, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 7/26/2016. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT DOES THE SURGEON BELIEVE WAS THE CAUSE OF THE BLEEDING? STAPLE LINE BLEEDING. IS AN AUTOPSY REPORT AVAILABLE? NO.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WHAT WAS THE SURGICAL PROCEDURE - BYPASS. WAS THERE ANY ISSUES NOTED WITH STAPLER PERFORMANCE DURING PROCEDURE - NO. WAS BUTTRESSING MATERIAL USED - NO.

    Additional Manufacturer Narrative · 1

    (B)(4) DATE SENT: 6/28/2016 BATCH # UNK ADDITIONAL INFORMATION RECEIVED: PROCEDURES: BYPASS ¿ SOME SLEEVE STAPLER: POWERED 1ST GENERATION PLE60A ¿ PSE60A RELOADS: ECR BLUE ON THE STOMACH ¿ WHITE ON BOWEL. ADDITIONAL INFORMATION REQUESTED BUT UNAVAILABLE: WHAT WAS THE SURGICAL PROCEDURE? WAS THERE ANY ISSUES NOTED WITH STAPLER PERFORMANCE DURING PROCEDURE? WAS BUTTRESSING MATERIAL USED? WHAT DOES THE SURGEON BELIEVE WAS THE CAUSE OF THE BLEEDING? IS AN AUTOPSY REPORT AVAILABLE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING AN UNKNOWN PROCEDURE, THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING. PATIENT COULDN'T BE OPERATED QUICK ENOUGH DUE TO A LATE MANAGEMENT OF THIS POST OPERATIVE BLEEDING BY THE NIGHT TEAM. EXACT PROCEDURE DATE WASN'T MENTIONED, PROBABLY AROUND (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409473 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death