BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASCUCLEAR PRECISION BIPOLAR

    MDR report key: 3902383 · Received June 24, 2014

    Report

    Report Number
    1718850-2014-00186
    Event Type
    Other
    Date Received
    June 24, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP RECEIVED A REPORT THAT THE JAW OF THE BIPOLAR BROKE DURING A VEIN HARVESTING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. A SORIN GROUP PROCEDURAL SPECIALIST WAS PRESENT AT THE TIME OF THE INCIDENT. THE PROCEDURAL SPECIALIST INDICATED THAT THE USER HAD ADVANCED THE DEVICE WITH THE JAWS OPEN. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE JAW OF THE BIPOLAR BROKE DURING A VEIN HARVESTING PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368478 VASCUCLEAR PRECISION BIPOLAR ELECTROSURGICAL, CUTTING AND COAGULATION AND ACCESSORIES GEI SORIN GROUP USA, INC. NA 1406900013

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR