BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC VEIN HARVESTING SYSTEM

    MDR report key: 12180658 · Received July 16, 2021

    Report

    Report Number
    1718850-2021-00039
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 21, 2021
    Report Date
    October 28, 2021
    Manufacturer
    LIVANOVA USA INC
    Product Code
    GEI
    PMA / PMN Number
    K102983
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    LIVANOVA RECEIVED A REPORT THE CAUTERY CABLE CAME APART INTO 2 PIECES ON THE FIELD. VISUAL INSPECTION OF THE RETURNED UNIT FOUND THE CABLE SEPARATED INTO TWO PIECES. THE RECEIVED HANDLE OF CABLE WAS PRINTED WITH ELMED PN 52005-42 LOT E0220. HOWEVER, LIVANOVA COULD NOT DETERMINE THE FULL TRACEABILITY OF THE FINISHED PRODUCT (EVH), SINCE THAT CABLE IS ONE A COMPONENT OF A LARGER DEVICE. REVIEW OF THE LIVANOVA COMPLAINT DATABASE DID NOT IDENTIFY ANY OTHER SIMILAR EVENT FOR THIS TYPE OF PRODUCT. THE EVENT IS AN ISOLATED CASE. LIVANOVA BELIEVES THE MOST PROBABLE ROOT CAUSE WAS A USER MISHANDLING: EXCESSIVE FORCE HAS BEEN APPLIED TO THE CABLE THUS CAUSING ITS UNSEATING FROM ITS HOUSING. THE RISK IS ACCEPTABLE. LIVANOVA WILL KEEP MONITORING THE MARKET FOR SIMILAR EVENTS.

    Description of Event or Problem · 0

    SEE INTIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. MODEL AND LOT OF THE COMPLAINED BIPOLAR UNKNOWN. THEREFORE, ALSO EXPIRATION DATE AND UDI ARE UNKNOWN. MODEL AND LOT OF THE COMPLAINED BIPOLAR UNKNOWN. THEREFORE, ALSO MANUFACTURING DATE IS UNKNOWN. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    LIVANOVA USA INC HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE CAUTERY CABLE CAME APART INTO 2 PCS ON THE FIELD. THE WIRES FELL OUT OF THE POTTING OF THE CABLE WITH THE BIPOLAR FCP STILL ATTACHED. THERE IS NO REPORT OF ANY PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1080444 ENDOSCOPIC VEIN HARVESTING SYSTEM ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI LIVANOVA USA INC E0220

    Patients

    Seq Age Sex Outcome Treatment
    1