BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARGLIDE EVH SMALL W/SCISSOR

    MDR report key: 1516929 · Received October 16, 2009

    Report

    Report Number
    1718850-2009-00051
    Event Type
    Malfunction
    Date Received
    October 16, 2009
    Date of Event
    September 15, 2009
    Report Date
    September 16, 2009
    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
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE FILED WHEN THIS INFORMATION IS AVAILABLE. ALL TRACEABILITY AND PRODUCT INFORMATION WAS DISCARDED BY THE HOSPITAL. NO LOT NUMBER OR EXPIRATION DATE IS AVAILABLE. THE 510(K) NUMBER FOR THE BIPOLAR DEVICE IS K003587. THIS DEVICE IS A COMPONENT IN THE CLEARGLIDE EVH SMALL KTV17 KIT. ALL TRACEABILITY AND PRODUCT INFORMATION WAS DISCARDED BY THE HOSPITAL. NO MANUFACTURE DATE IS AVAILABLE. THE OR MATERIALS MANAGER REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE BROKE OFF INSIDE OF THE PATIENT. UNFORTUNATELY, THE PRODUCT WAS DISCARDED BY THE HOSPITAL. WITH NO TRACEABILITY, MANUFACTURING RECORDS CANNOT BE REVIEWED. WITHOUT THE PHYSICAL DEVICE, THE CAUSE OF THE REPORTED PROBLEM CANNOT BE DETERMINED. THE 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".

    Description of Event or Problem · 1

    THE OR MATERIALS MANAGER REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE ENDOSCOPIC VEIN HARVESTING BIPOLAR DEVICE BROKE OFF INSIDE OF THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1