BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP APPLIER - MEDIUM

    MDR report key: 2041971 · Received April 6, 2011

    Report

    Report Number
    1527736-2011-00087
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 11, 2011
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GDO
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED WITH THE JAWS MISALIGNED. IN AN ATTEMPT TO REPLICATE THE REPORTED INCIDENT, THE DEVICE WAS TESTED FOR FUNCTIONALITY. UPON TESTING, THE DEVICE LOADED, RETAINED AND FORMED FIVE CLIPS CONFORMING; HOWEVER, DUE TO THE CONDITION OF THE JAWS ONE CLIP WITH GAP WAS FORMED. A POSSIBLE CAUSE OF THIS CONDITION MAY BE THE INCORRECT/EXCESSIVE APPLICATION OF TORQUE TO THE JAWS DURING INSTRUMENT USE CREATES A MISALIGNMENT OF THE TIPS WHICH MAY RESULT IN CLIP MALFORMATION. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY BYPASS GRAFT PROCEDURE, THE CLIP APPLIER JAW WAS NOT HOLDING CLIPS PROPERLY, RESULTING IN IMPROPER CLOSURE OF CLIPS. UNKNOWN HOW CASE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLIP APPLIER - MEDIUM CLIP APPLIER - MEDIUM GDO ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1