BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX 2.7

    MDR report key: 1881196 · Received October 6, 2010

    Report

    Report Number
    3005473391-2010-00019
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    July 9, 2009
    Report Date
    October 5, 2010
    Product Code
    ODE
    PMA / PMN Number
    K071651
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: BASED ON THE F/U EVAL, NO MATERIAL OR PROCESS DEFECT WAS FOUND. THE INFO OBTAINED DURING THE INVESTIGATION IN CONNECTION WITH THE ENGINEERING EVAL WOULD INDICATE THAT EXCESSIVE FORCE WAS USED BY THE OPERATOR TO CAUSE THE MATERIAL FAILURE. THIS MALFUNCTION REPORT IS NOW BEING REPORTED AFTER WRITTEN FEEDBACK FROM (B)(4) REGARDING THIS FAILURE TYPE. DUE TO THE TIME LAPSE AND NO PT ISSUES, PT INFO COULD NOT BE ACQUIRED.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED A PORTION OF THE HELIX TIP CAME OFF IN THE PT'S STOMACH TISSUE APPROX 3 TO 5 CM FROM THE GASTROESOPHAGEAL JUNCTION AND WAS SUCCESSFULLY RETRIEVED USING ENDOSCOPIC FORCEPS. THE END OF THE TIP BROKE WHEN ATTEMPTING TO RELEASE THE HELIX FROM THE TISSUE AT THE COMPLETION OF THE PROCEDURE. THE HELIX BECAME CAUGHT IN A WRAP OF TISSUE. THE BREAKAGE DID NOT CAUSE ADD'L TRAUMA BEYOND THE RELATIVELY MILD TISSUE TRAUMA TYPICALLY EXPERIENCED DURING THE SURGICAL PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND DEVICE. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX 2.7 ODE 2.7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK