BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLEARGLIDE EVH SMALL

    MDR report key: 2069573 · Received April 15, 2011

    Report

    Report Number
    1718850-2011-00024
    Event Type
    Other
    Date Received
    April 15, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    GEI
    PMA / PMN Number
    K003587
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP USA RECEIVED A REPORT THAT THE TIP OF THE BIPOLAR DEVICE BROKE OFF. THE TIP WAS RETRIEVED AND THERE WAS NO HARM TO THE PT. THE BIPOLAR DEVICE WAS RETURNED TO SORIN GROUP USA FOR EVAL. VISUAL INSPECTION CONFIRMED THAT THE LOWER JAW WAS BROKEN. THE BROKEN PIECE IS CURVED, WHICH SUGGESTS THAT THE BREAKAGE WAS CAUSED BY THE LOWER JAW BEING BENT AWAY FROM THE UPPER JAW WITH SIGNIFICANT FORCE. THE SORIN CLEARGLIDE BIPOLAR INSTRUCTIONS FOR USE STATE, "DO NOT ADVANCE OR TORQUE THE INSTRUMENT WITH THE JAWS OPEN OR USE THE JAWS FOR SPREAD DISSECTION. THESE ACTIONS WILL DAMAGE THE INSTRUMENT." THERE WAS NO REPORT OF PT COMPLICATION DUE TO THE INCIDENT. THE FACILITY REPORTED THAT THE DEVICE BROKE OFF IN THE PT. THIS MEDWATCH IS BEING FILED AS A RESULT OF THIS REPORT.

    Description of Event or Problem · 1

    THE TIP OF THE ENDOSCOPIC VEIN HARVESTING DEVICE BROKE OFF. THE TIP WAS RETRIEVED AND THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARGLIDE EVH SMALL BIPOLAR DEVICE GEI SORIN GROUP USA, INC. NA 1034000079

    Patients

    Seq Age Sex Outcome Treatment
    1 NP