BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTREE II 5-12MM VALVE/REDUCER

    MDR report key: 1622490 · Received February 26, 2010

    Report

    Report Number
    1320894-2010-00020
    Event Type
    Injury
    Date Received
    February 26, 2010
    Date of Event
    January 29, 2010
    Report Date
    February 25, 2010
    Manufacturer
    CONMED CORPORATION
    Product Code
    FBM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO FROM FACILITY WITHOUT COOPERATION. AT THIS TIME, IT IS UNK IF THE SEAL WAS RETRIEVED FROM THE PT. CONMED WILL CONTINUE TO ATTEMPT TO GATHER ADD'L INFO; HOWEVER, USER FACILITY APPEARS TO BE UNWILLING TO ANSWER QUESTIONS. ONCE AN INVESTIGATION, AND FURTHER ATTEMPTS TO GATHER ADD'L INFO HAVE BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED: "THE DOCTOR WAS PERFORMING A LAP NISSEN FUNDOPLICATION ON JAN 29TH, AND THAT THE PT CAME BACK TO THE HOSP THE VERY NEXT DAY ON THE 30TH DUE TO COMPLICATIONS HAVING NOTHING TO DO WITH THE CORE TROCAR. DURING THE PT'S 2ND VISIT TO THE HOSP, SOMEHOW IT WAS DISCOVERED THAT A PORTION OF THE CORE DYNAMIC SEAL WAS LEFT INSIDE THE PT. IT IS NOT KNOWN EXACTLY HOW IT GOT THERE, NOR IT IS KNOWN HOW IT WAS NOT NOTICED AT THE TIME OF THE ACTUAL PROCEDURE. AT THE BEGINNING OF THE CASE, AS WELL AS DURING THE CASE THE DOCTOR STRUGGLED TO INSERT INSTRUMENTS THROUGH THE SEAL OF THE TROCAR THE DOCTOR WAS VERY ROUGH WITH THE INSERTION OF INSTRUMENTS, AND APPEARED TO BE CATCHING ON THE SEAL ON THE WAY INTO THE CANNULA. THE DOCTOR SEEMED TO HAVE TO FORCE THE INSTRUMENT THROUGH THE SEAL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTREE II 5-12MM VALVE/REDUCER ENTREE II 5-12 MM VALVE/REDUCER FBM CONMED CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization| R