BEUDAMED
    FDA Adverse Event Other Summary report: N

    VC EVH. OD. SMR. VD. BP

    MDR report key: 2111521 · Received May 17, 2011

    Report

    Report Number
    1718850-2011-00040
    Event Type
    Other
    Date Received
    May 17, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K102983
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS REQUESTED. IF RECEIVED, A FOLLOW-UP REPORT WILL BE FORWARDED. THE VISUAL INSPECTION FOUND THAT THE PLASTIC ON THE JAWS HAD EVIDENCE OF BEING WORN OFF FROM CONTACT WITH THE METAL GUIDE. A CLOSER EXAM FOUND THAT THE UPPER MEATAL GUIDE SECTION HAD BEEN BENT OUTWARD. THE JAWS WERE INITIALLY STUCK CLOSED, BUT AFTER REMOVING THE DRY BLOOD, THE JAWS OPENED AND CLOSED WITH LITTLE RESISTANCE. AUTOPSY REVEALED DRIED BLOOD ALONG THE ENTIRE LENGTH OF THE BLADE SHAFT AND BLADE GUIDES, THE INNER SHAFT AND UP INSIDE THE HANDLE. THE ANALYSIS OF THE BIPOLAR DEVICE INDICATES THAT THE PROBLEM EXPERIENCED BY THE CLINICIAN WAS CAUSED BY CLAMPING EXCESSIVE TISSUE IN THE JAWS AS INDICATED BY BENDING OF THE METAL GUIDE, AND THE GENERATION OF THE PLASTIC FRAGMENTS. THE INSTRUCTIONS FOR USE STATE: "TO ENSURE THAT THE INSTRUMENT WILL CLOSE PROPERLY, DO NOT INSERT TOO MUCH TISSUE IN THE JAWS", "DO NOT ADVANCE OR TORQUE THE INSTRUMENT WITH THE JAWS OPEN OR USE THE JAWS FOR SPREAD DISSECTION. THESE ACTIONS WILL DAMAGE THE INSTRUMENT", AND "EXCESSIVE TISSUE ACCUMULATED WITHIN THE JAWS MAY PREVENT KNIFE BLADE FROM FULLY RETURNING TO ITS NEUTRAL POSITION...". NO FURTHER EVAL IS DEEMED NECESSARY.

    Description of Event or Problem · 1

    SORIN GROUP USA RECEIVED A REPORT THAT THE JAWS OF A BIPOLAR DEVICE WERE JAMMING DURING THE DISTAL HARVEST OF THE VEIN. IT WAS NOTED THAT FRAGMENTS FROM THE UPPER JAW WERE WORN OFF DURING THIS PROCEDURE. THE CLINICIAN REMOVED THE FRAGMENTS VIA SUCTION. THERE WAS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VC EVH. OD. SMR. VD. BP BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 1108200001

    Patients

    Seq Age Sex Outcome Treatment
    1