BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOTAL KNEE PACK - LF

    MDR report key: 2083089 · Received April 26, 2011

    Report

    Report Number
    1417592-2011-00023
    Event Type
    Other
    Date Received
    April 26, 2011
    Date of Event
    March 31, 2011
    Report Date
    April 26, 2011
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE COATING OF THE CAUTERY TIP WAS FLAKING AND PIECES FELL INTO THE SURGICAL SITE. THE SURGEON IRRIGATED THE SITE AND NO INJURY RESULTED FOR THE PATIENT. THE SAMPLE WAS RETURNED AND INSPECTED. THE TIP WAS FOUND TO HAVE BURNT TISSUE ON IT. THIS TIP IS MANUFACTURED BY BOVIE. THE SAMPLE IS BEING FORWARDED TO BOVIE FOR FURTHER REVIEW AND DETERMINATION OF THE NEED FOR ANY CORRECTIVE ACTION. WE HAVE NO TRENDS FOR THIS ISSUE WITH THIS VENDOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COATING ON THE CAUTERY TIP WAS FLAKING INTO THE SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL KNEE PACK - LF NONE GEI DYNJ14128K 11BD1152

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention