BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESO-SPONGE OV.13 MM

    MDR report key: 5183673 · Received October 28, 2015

    Report

    Report Number
    2916714-2015-00977
    Event Type
    Death
    Date Received
    October 28, 2015
    Report Date
    January 19, 2016
    Manufacturer
    AESCULAP AG
    Product Code
    EFQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR ANY OTHER TECHNOLOGICAL CHARACTERISTICS WITH A MEDICAL DEVICE RESISTED WITHIN THE U.S. ARE. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT REPORTED IN THIS MEDWATCH REPORT OCCURRED IN (B)(6); THE ITEM INVOLVED IS MANUFACTURED BY BBRAUN SURGICAL (B)(4) AND WAS INCORRECTLY REPORTED TO BE MANUFACTURED BY AESCULAP (B)(4). THIS ITEM IS NOT MARKETED IN THE UNITED STATES. THE REPORT WAS SUBMITTED DUE TO HUMAN ERROR RELATED TO DETERMINATION OF REPORTABILITY. THERE ARE NO SIMILAR PRODUCTS MARKETED IN THE UNITED STATES. REMOVAL FROM THE MAUDE DATABASE WAS REQUESTED ON 01/06/2016. REQUEST WAS DENIED ON 01/15/2016. IT WAS RECOMMENDED THAT A FOLLOW UP REPORT BE SUBMITTED WITH INFORMATION ENTERED INTO THIS SECTION.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). PATIENTS HAD GASTRIC CARCINOMA. POSTOPERATIVELY, THE PATIENT SHOWED AN ANASTOMOTIC LEAK BETWEEN STOMACH AND THE ESOPHAGUS. ON WEDNESDAY A DIAGNOSES AND A DECISION WAS MADE TO TREAT IT WITH ESO-SPONGE. FRIDAY MORNING, THE FIRST TREATMENT WITH ESO- SPONGE, WAS TOLD BY THE DOCTOR, THE DISEASE HAS PROGRESSED VASTLY. IN THE MEANTIME, FINDINGS ON FRIDAY, THE INSUFFICIENCY CAVITY WAS MUCH MORE EXTENSIVE, THAN ON WEDNESDAY. A 13MM OVERTUBE AND A PUMP WASN USED. ON FRIDAY EVENING, THE PATIENT SHOWED MASSIVE BLEEDINGS. THE BLEEDING RAN ALL OVER THE ABDOMINAL AND THE DRAINAGE WAS LOCATED IN THE PUMP AS WELL. IN THE CAUSE OF THE HEAVY BLEEDINGS, THE PATIENT PAST AWAY ON FRIDAY EVENING. NO DATES WERE GIVEN. THE SURGEON EVALUATED, THAT FROM HIS SIGHT, ESO-SPONGE WAS THE ONLY CHANCE TO SOLVE THIS PROBLEM. THE PATIENT WOULD NOT HAVE OVERCOME A RE-OPERATION. DUE TO THE FACT, THAT THE PATIENT PASSED AWAY, THIS WILL BE TRACED BACK TO THE HEAVINESS OF THE CLINICAL EVIDENCE/FINDINGS AND THE BAD CONDITION OF THE PATIENT HIMSELF AT THAT TIME. IF THE SPONGE WOULD HAVE BEEN PLACED, MOST PRESUMABLY THE BLEEDING WOULD MOST PRESUMABLY HAVE OCCURRED ONE OR TWO DAYS LATER. THE SURGEON DOES NOT BLAME ESO-SPONGE FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715043 ESO-SPONGE OV.13 MM ESO-SPONGE EFQ AESCULAP AG 5526550 215215

    Patients

    Seq Age Sex Outcome Treatment
    1 Death