BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESOPHYX2 -04

    MDR report key: 1881001 · Received October 6, 2010

    Report

    Report Number
    3005473391-2010-00022
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Date of Event
    October 9, 2009
    Report Date
    October 5, 2010
    Manufacturer
    REDMOND
    Product Code
    ODE
    PMA / PMN Number
    K092400
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: THE PRODUCT WAS NOT RETURNED; THEREFORE, CONFIRMATION OF THE PRODUCT MALFUNCTION WAS NOT POSSIBLE. EVAL WAS BASED ON ANALYSIS OF THE DHR AND COMPLAINT TRENDING. FINDINGS: IT IS SUSPECTED THAT THE SERVICE LOOP DISCONNECTED FROM THE TISSUE MOLD ELBOW DUE TO A MFG PROCESS ISSUE. (B)(4), RELEASED ON (B)(6) 2009 VALIDATED A CHANGE TO THE BONDING PROCESS WHICH INCREASED THE PROCESS CAPABILITY CPK FROM 1.0 TO 1.78. THIS MALFUNCTION REPORT IS NOW BEING REPORTED AFTER WRITTEN FEEDBACK FROM CDRH REGARDING THIS FAILURE TYPE. DUE TO THE TIME LAPSE AND NO PATIENT ISSUES, PT INFO COULD NOT BE ACQUIRED.

    Description of Event or Problem · 1

    THE COMPANY REP REPORTED THAT THE AFTER RETRACTING TISSUE VERY AGGRESSIVELY AT ENGAGEMENT 4, THE HELICAL RETRACTOR SERVICE LOOP DETACHED FROM THE TISSUE MOLD. NO PROBLEMS WITH DEVICE REMOVAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESOPHYX2 -04 ODE REDMOND R2000 400405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK