BEUDAMED
    FDA Adverse Event Death Summary report: N

    ETS FLEX ARTICNG LNR

    MDR report key: 2495136 · Received March 19, 2012

    Report

    Report Number
    3005075853-2012-01197
    Event Type
    Death
    Date Received
    March 19, 2012
    Date of Event
    February 6, 2012
    Report Date
    February 21, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. USER FACILITY MEDWATCH ATTACHED. SPOKE WITH RISK MANAGER AT THE ACCOUNT, SHE INDICATED THAT THE PATIENT WAS IN VERY POOR HEALTH, HE HAD RECEIVED LITTLE TO NO HEALTH CARE. THE PROCEDURE WAS VERY DIFFICULT AND THE DEVICE MALFUNCTION DID NOT HELP THE SITUATION. THERE WAS BLEEDING WHEN WENT INTO THE PROCEDURE, THE PATIENT HAD A FOOTBALL SIZE HEMORRHAGIC TUMOR. WHEN FIRING THE GUN THE DEVICE CUT AND THE STAPLES REMAINED OPEN. IT WAS NOT THE FIRST FIRING OF THE DEVICE, BUT THE DEVICE WAS NOT USED AFTER THE DIFFICULTY WAS ENCOUNTERED. RISK MANAGER INDICATED SHE WILL NOT BE FILING THIS AS A SENTINEL EVENT. DR. IS NOT EMPLOYED BY THE HOSPITAL. THE DEVICE WAS DISCARDED AT THE TIME OF THE OPERATION. THE SURGERY WAS NOT RECORDED AND NO AUTOPSY WAS PERFORMED. THREE MESSAGES FOR THE SURGEON HAVE BEEN LEFT TO DATE, NO RESPONSE HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. USER FACILITY MEDWATCH ATTACHED. SPOKE WITH RISK MANAGER AT THE ACCOUNT, SHE INDICATED THAT THE PATIENT WAS IN VERY POOR HEALTH, HE HAD RECEIVED LITTLE TO NO HEALTH CARE. THE PROCEDURE WAS VERY DIFFICULT AND THE DEVICE MALFUNCTION DID NOT HELP THE SITUATION. THERE WAS BLEEDING WHEN WENT INTO THE PROCEDURE, THE PATIENT HAD A FOOTBALL SIZE HEMORRHAGIC TUMOR. WHEN FIRING THE GUN, THE DEVICE CUT AND THE STAPLES REMAINED OPEN. IT WAS NOT THE FIRST FIRING OF THE DEVICE, BUT THE DEVICE WAS NOT USED AFTER THE DIFFICULTY WAS ENCOUNTERED. RISK MANAGER INDICATED SHE WILL NOT BE FILING THIS AS A SENTINEL EVENT. DR. IS NOT EMPLOYED BY THE HOSPITAL. THE DEVICE WAS DISCARDED AT THE TIME OF THE OPERATION. THE SURGERY WAS NOT RECORDED AND NO AUTOPSY WAS PERFORMED. THREE MESSAGES FOR THE SURGEON HAVE BEEN LEFT TO DATE, NO RESPONSE HAS BEEN RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. SPOKE WITH RISK MANAGER AT THE ACCOUNT, SHE INDICATED THAT THE PATIENT WAS IN VERY POOR HEALTH, HE HAD RECEIVED LITTLE TO NO HEALTH CARE. THE PROCEDURE WAS VERY DIFFICULT AND THE DEVICE MALFUNCTION DID NOT HELP THE SITUATION. THERE WAS BLEEDING WHEN WENT INTO THE PROCEDURE, THE PATIENT HAD A FOOTBALL SIZE HEMORRHAGIC TUMOR. WHEN FIRING THE GUN THE DEVICE CUT AND THE STAPLES REMAINED OPEN. IT WAS NOT THE FIRST FIRING OF THE DEVICE, BUT THE DEVICE WAS NOT USED AFTER THE DIFFICULTY WAS ENCOUNTERED. RISK MANAGER INDICATED SHE WILL NOT BE FILING THIS AS A SENTINEL EVENT. DR. IS NOT EMPLOYED BY THE HOSPITAL. THE DEVICE WAS DISCARDED AT THE TIME OF THE OPERATION. THE SURGERY WAS NOT RECORDED AND NO AUTOPSY WAS PERFORMED. THREE MESSAGES FOR THE SURGEON HAVE BEEN LEFT TO DATE, NO RESPONSE HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS FLEX ARTICNG LNR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H44X4A

    Patients

    Seq Age Sex Outcome Treatment
    1