BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENSEAL SUPER JAW

    MDR report key: 2333357 · Received November 11, 2011

    Report

    Report Number
    3005075853-2011-04905
    Event Type
    Death
    Date Received
    November 11, 2011
    Date of Event
    October 27, 2011
    Report Date
    November 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GEI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION NOT ASKED FOR BUT UNKNOWN OR PROVIDED DURING INITIAL CONTACT. DATE OF EACH WAS (B)(6). ASSUMED (B)(6) 2011 AS EMDR REQUIRES A COMPLETE DATE. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION PROVIDED BY SALES REP: REP SAW THE ANESTHESIOLOGIST ON (B)(6) 2011, IN THE ELEVATOR A FEW DAYS AFTER THE SURGERY. THE ANESTHESIOLOGIST SAID THAT HE WAS SURPRISED THAT SURGEON WENT THROUGH WITH THE PROCEDURE, LOW PROBABILITY OF SUCCESS WITH PATIENT. THE OPERATING ROOM CALLED IN FOR 4 UNITS OF BLOOD BUT AS THE REP HAD LEFT THE ROOM, HE IS UNSURE IF ALL 4 UNITS WERE USED. THE PROCEDURE WAS ON (B)(6). WHEN THE REP SAW THE ANESTHESIOLOGIST ON (B)(6), THE PATIENT HAD ALREADY DIED. THE PATIENT DIED 2-3 DAYS AFTER THE PROCEDURE. THE PATIENT HAD PREVIOUSLY HAD A WHIPPLE PROCEDURE. NOT SENDING I-BLADE DOWN) SURGEON HAS BEEN CONTACTED MULTIPLE TIMES INCLUDING EMAIL AND FAX. SURGEON HAS READ EMAIL BUT HAS NOT RESPONDED .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OP OF AN OPEN DISTAL PANCREATECTOMY WITH SPLENECTOMY. THE SALES REP WAS NOTIFIED BY THE ATTENDING ANESTHESIOLOGIST THAT THE PATIENT HAD EXPIRED A FEW DAYS AFTER THE PROCEDURE. DURING THE ORIGINAL PROCEDURE WHEN THE SURGEON WAS WORKING NEAR AN ARTERY OR VESSEL BLOOD BEGAN SPURTING PROFUSELY. THEY USED CLAMPS AND SUTURE BUT THE PATIENT REQUIRED 4 KNOWN UNITS OF BLOOD AND POSSIBLY REQUIRED MORE. THE EES DEVICE HAD NOT BEEN USED FOR OVER THIRTY MINUTES WHEN THE BLEEDING OCCURRED DURING THE PROCEDURE. THE PATIENT WAS IN THE ICU AFTER THE PROCEDURE, BUT IS IT NOT KNOWN WHEN THE ACTUAL DEATH OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENSEAL SUPER JAW ENSEAL SUPER JAW GEI ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GENERATOR