BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAUTERY TIP WITHIN CUSTOM JOINT PACK

    MDR report key: 2650431 · Received July 2, 2012

    Report

    Report Number
    1417592-2012-00053
    Event Type
    Other
    Date Received
    July 2, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 26, 2012
    Manufacturer
    BOVIE MEDICAL
    Product Code
    GEI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN ORTHOPEDIC SURGICAL PROCEDURE, A PIECE OF THE CAUTERY TIP WAS THOUGHT TO BE BROKEN OFF THE TIP. X-RAYS WERE PERFORMED TO CONFIRM IT WAS NOT IN THE SURGICAL SITE AND THE TIP WAS NEVER LOCATED. THERE WAS NO INJURY TO THE PT. IT IS NOT KNOWN IF THE TIP WAS MANIPULATED IN ANY WAY PRIOR TO OR DURING USE. NO LOT NUMBER WAS REPORTED AND THE CAUTERY TIP BASE WAS NOT RETURNED FOR EVALUATION. THE CAUTERY TIP IN THIS CUSTOM PACK IS MANUFACTURED BY BOVIE MEDICAL. THEY HAVE BEEN NOTIFIED OF THE INCIDENT.

    Description of Event or Problem · 1

    DURING AN ORTHOPEDIC PROCEDURE, THE CAUTERY TIP BROKE. NO INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAUTERY TIP WITHIN CUSTOM JOINT PACK GEI BOVIE MEDICAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention