BEUDAMED
    FDA Adverse Event Summary report: N

    TROCAR SLEEVE 5/110MM THREADED

    MDR report key: 4860028 · Received June 5, 2015

    Report

    Report Number
    2916714-2015-00476
    Date Received
    June 5, 2015
    Date of Event
    February 14, 2015
    Report Date
    June 5, 2015
    Manufacturer
    AESCULAP AG & CO. KG
    Product Code
    GCJ
    PMA / PMN Number
    K101937
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: THE RECEIVED TROCAR HAS BURRS. THE DEFORMATION AT THE END OF THE TROCARS IS USER RELATED. THE TROCARS ARE INSPECTED 100% PRIOR TO RELEASE FOR DISTRIBUTION. A MANUFACTURING ERROR IS EXCLUDED. THE BURRS ARE RESPONSIBLE FOR THE SHEARING OFF OF THE GRASPER'S SHEATH. THE PRODUCT IFU INDICATES EACH DEVICE SHOULD BE INSPECTED PRIOR TO USE. CORRECTIVE ACTION IS NOT REQUIRED.

    Description of Event or Problem · 1

    COUNTRY OF COMPLAINT: (B)(6). DURING OPERATION, THE SURGEON FOUND A STRIP OF INSULATION IN THE PATIENT'S ABDOMINAL CAVITY - ON INVESTIGATION IT WAS FOUND TO BE THE INSULATION FROM THE GRASPER'S SHEATH. IT HAS BEEN SUGGESTED BY THE CUSTOMER THAT THE CAUSE OF THE INCIDENTS WAS DUE TO THE TROCARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366371 TROCAR SLEEVE 5/110MM THREADED TROCAR GCJ AESCULAP AG & CO. KG EK017R

    Patients

    Seq Age Sex Outcome Treatment
    1