BEUDAMED
    FDA Adverse Event Death Summary report: N

    EEA 28MM SINGLE-USE STAPLER

    MDR report key: 6051907 · Received October 24, 2016

    Report

    Report Number
    2647580-2016-00865
    Event Type
    Death
    Date Received
    October 24, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 4, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GDW
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, ACCORDING TO THE REPORTER, THE SURGEON WAS LEFT LOOKING AT A COLOSTOMY IN THE RECTUM WHERE THE ANVIL WAS SEWN IN PLACE AND THERE WAS NO STAPLE LINE. AT THE TIME, THE PATIENT WAS RECOVERING, WITH AN OPEN ABDOMEN, FROM SEVERE SEPSIS DUE TO C DIFF. HE HAD PREVIOUSLY UNDERGONE AN EMERGENT SUBTOTAL COLECTOMY FOR THE ABOVE CONDITION. THE ANASTOMOSIS WAS A PLANNED BAKER TYPE: TERMINAL ILEUM TO RECTUM. WITH DEVICE FAILURE THE DECISION WAS MADE TO RESECT THE DAMAGED TI AND HAND-SEW THE ILEO-RECTAL ANASTOMOSIS. NO STAPLES WERE DEPLOYED AND THE ENTEROTOMY AND COLOSTOMY WERE MADE BY THE STAPLER WITHOUT DEPLOYING THE STAPLES. THE PATIENT IS NOW DECEASED FROM AN UNRELATED CAUSE. THERE WAS UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM. THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, WHEN THE DOCTOR FIRED THE DEVICE, THE KNIFE DEPLOYED BUT IT DID NOT FIRE ANY STAPLE. SHE COMPLETED THE CASE BY DOING A HAND SEWN ILEO-RECTAL ANASTOMOSIS. AS OF TODAY, THE PATIENT IS DOING WELL ACCORDING TO THE SURGEON. THE PATIENT HAD C-DIF PRIOR TO THE CASE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703444 EEA 28MM SINGLE-USE STAPLER STAPLE, IMPLANTABLE GDW COVIDIEN, FORMERLY USSC PUERTO RICO INC EEA28

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention