BEUDAMED
    FDA Adverse Event Death Summary report: N

    NA

    MDR report key: 3144598 · Received May 31, 2013

    Report

    Report Number
    2134070-2013-00119
    Event Type
    Death
    Date Received
    May 31, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 10, 2013
    Manufacturer
    STERILMED, INC.
    Product Code
    NMJ
    PMA / PMN Number
    K033579
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MFR AND WAS REPORTED TO BE DISCARDED BY THE USER FACILITY. ETHICON ENDO-SURGERY, LLC IS CONDUCTING A VOLUNTARY RECALL OF CERTAIN MODEL ER320 DEVICES. STERILMED INITIATED A PASS THROUGH RECALL OF ALL OF ITS ER320 DEVICES ON (B)(6) 2013 AND NOTIFIED ITS CUSTOMERS OF THE RECALL ON THAT DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED IN A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2013 AROUND 11:00AM. ON (B)(6) 2013, THE PT HAD BLEEDING IN THE ICU AND WAS BROUGHT BACK TO THE OPERATING ROOM. THE CYSTIC ARTERY WAS BLEEDING, THERE WAS NO CLIP AND THE PT RECEIVED SEVERAL UNITS OF BLOOD AND FRESH FROZEN PLASMA. THE PT RETURNED TO THE ICU. THE PT RECEIVED SEVERAL MORE UNITS OF BLOOD OVERNIGHT. ON (B)(6) 2013, THE ABDOMEN WAS DISTENDED. IT WAS DECOMPRESSED IN THE ICU AND SEVERAL UNITS OF BLOOD WERE PULLED OFF. THE PT WAS RESUSCITATED. THE PT DIED ON (B)(6) 2013 FROM HEMORRHAGING. THE DEVICE WAS DISCARDED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PT, PROCEDURE AND THE DEVICE, BUT NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240184 NA NMJ STERILMED, INC. ETHER320

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R