BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAFETY SCALPEL WITHIN CUSTOM TRAY

    MDR report key: 2608667 · Received June 5, 2012

    Report

    Report Number
    1417592-2012-00040
    Event Type
    Other
    Date Received
    June 5, 2012
    Date of Event
    April 25, 2012
    Report Date
    May 30, 2012
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    GES
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER USING THE SCALPEL FROM THIS CUSTOM PACK, THE SURGEON ADVANCED THE SAFETY SHIELD AND IT APPARENTLY FLEW OFF THE HANDLE AND HIT THE FACE SHIELD OF A NEARBY CLINICIAN. THERE WAS NO INJURY TO THE CLINICIAN AND MEDICAL INTERVENTION WAS NOT INDICATED. THE SAMPLE WAS RETURNED AND INSPECTED. THE BLADE FIT SECURELY ONTO THE HANDLE. THERE WERE NO SIGNS OF STRESS AT THE CONNECTION. THE SAFETY SHIELD SLID SMOOTHLY WHEN THE BUTTON WAS ACTIVATED AND LOCKED SECURELY AND CORRECTLY INTO PLACE. WHEN THE SHIELD IS LOCKED IN PLACE, THE BLADE CAN BE REMOVED FROM THE HANDLE. IF SIGNIFICANT PRESSURE IS APPLIED DURING THE REMOVAL PROCESS, IT IS POSSIBLE TO REPLICATE THE SUDDEN DETACHMENT FROM THE HANDLE AS DESCRIBED IN THIS INCIDENT. WE IDENTIFIED NO CONCERNS WITH THE FUNCTION AND/OR OPERATION OF THIS SAFETY SCALPEL. THIS IS A BD BARD-PARKER BLADE. ASPEN SURGICAL PRODUCTS, INC. OWNS THIS LINE OF SURGICAL BLADES. THEY HAVE BEEN NOTIFIED OF THIS INCIDENT IN ORDER THAT THEY MAY CONDUCT AN INVESTIGATION AND DETERMINE THE NEED FOR ANY CORRECTIVE ACTION.

    Description of Event or Problem · 1

    AFTER USING THE SCALPEL, THE SURGEON ADVANCED THE SAFETY SHIELD AND THE BLADE APPARENTLY CAME OFF THE HANDLE AND HIT A CLINICIAN'S FACE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETY SCALPEL WITHIN CUSTOM TRAY GES ASPEN SURGICAL PRODUCTS, INC. 0000852

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other