BEUDAMED
    FDA Adverse Event Other Summary report: N

    STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)

    MDR report key: 1662761 · Received April 15, 2010

    Report

    Report Number
    1718850-2010-00020
    Event Type
    Other
    Date Received
    April 15, 2010
    Date of Event
    September 11, 2009
    Report Date
    September 18, 2009
    Manufacturer
    SORIN GROUP, DEUTSCHLAND
    Product Code
    DXC
    PMA / PMN Number
    K082344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE S5 SYSTEM AND THE 510(K) NUMBER IS K082344. THE EVO CLAMP IS A PART OF THE S5 SYSTEM. THE INCIDENT OCCURRED AT (B)(6). THIS MEDWATCH REPORT IS FILED ON BEHALF OF SORIN GROUP (B)(4). PLEASE NOTE THAT THIS MDR IS BEING FILED LATE DUE TO A RECENT CHANGE IN SORIN GROUP (B)(4) MEDWATCH REPORTING CRITERIA AND SUBSEQUENT REVIEW OF PAST COMPLAINTS TO THE NEW CRITERIA. DURING THE TEC PROCEDURE, THE CLAMP CONTROL MADE A NOISE AND WOULD NOT FUNCTION PROPERLY DESPITE SEVERAL ATTEMPTS BY THE CLINICIAN. THERE WERE NO PT CONSEQUENCES. THE CLAMP CONTROL UNIT WAS RETURNED TO SORIN GROUP (B)(4) FOR EVAL. THE DESCRIBED PROBLEM COULD NOT BE REPRODUCED. THE UNIT WAS TESTED INTENSIVELY FOR APPROXIMATELY 600 HOURS. BUT NO PROBLEM OR FAULT COULD BE FOUND. NO FURTHER ACTION IS NECESSARY.

    Description of Event or Problem · 1

    DURING THE TEC PROCEDURE, THE CLAMP CONTROL MADE A NOISE AND WOULD NOT FUNCTION PROPERLY DESPITE SEVERAL ATTEMPTS BY THE CLINICIAN. THERE WERE NO PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) CLAMP VASCULAR, CARDIOPULMONARY DXC SORIN GROUP, DEUTSCHLAND NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1