BEUDAMED
    FDA Adverse Event Other Summary report: N

    INS NO-STK MF 7"

    MDR report key: 1371654 · Received February 13, 2009

    Report

    Report Number
    1226348-2009-00017
    Event Type
    Other
    Date Received
    February 13, 2009
    Date of Event
    January 15, 2009
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEI
    PMA / PMN Number
    K963499
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. IT IS UNCLEAR AT THIS POINT IF A PT WAS INVOLVED. HOWEVER, AS A CONSERVATIVE MEASURE, THIS COMPLAINT IS BEING REPORTED.

    Description of Event or Problem · 1

    IT WAS FOUND THAT THE COATING OF THE TIP PEELED OFF AFTER USE. ADDITIONAL INFO FROM THIS HOSPITAL EXPLAINED, THIS PRODUCT WAS USED BY SOME SURGEONS, DEPARTMENT OF NEUROSURGERY, ORTHOPEDICS AND ONTOLOGICAL. THEREFORE, IT COULD NOT BE DETERMINE WHO USED THIS PRODUCT FOR SURGERY. IT WAS FOUND THE COATING HAD PEELED OFF AFTER THE STERILIZATION PROCESS. ACCORDING TO THE DOCTOR, IT COULD NOT BE DETERMINED IF THE COATING REMAINED IN THE PT'S BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INS NO-STK MF 7" ELECTROSURGICAL, CUTTING & COAG & ACCESS GEI CODMAN & SHURTLEFF, INC. NA 360281

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention