BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL BLADE #15 IN CUSTOM PAK

    MDR report key: 3076528 · Received April 18, 2013

    Report

    Report Number
    1423395-2013-00007
    Event Type
    Injury
    Date Received
    April 18, 2013
    Date of Event
    March 21, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC
    Product Code
    GES
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE BEGINNING OF AN ARTHROSCOPIC KNEE PROCEDURE, THE SURGEON MADE A SMALL INCISION WITH THE SURGICAL BLADE AND VISUALIZED WHAT APPEARED TO BE A SILVER COLORED RESIDUE AROUND THE WOUND. HE TOUCHED THE SURGICAL BLADE AND A PIECE CLOSE TO WHERE IT ATTACHES TO THE HANDLE BROKE OFF. THE SURGEON EXCISED A 1MM AREA TO REMOVE THE SILVER COLORED RESIDUE AND CLOSED THE INCISION WITH SUTURES. THIS IS A BARD-PARKER CARBON RIB-BACK BLADE FROM ASPEN SURGICAL PRODUCTS, INC AND IS A COMPONENT IN A CUSTOM SURGICAL PACK. THEY HAVE BEEN NOTIFIED OF THIS INCIDENT AND THE SAMPLE HAS BEEN SENT TO THEM IN ORDER THAT THEY MAY CONDUCT AN INVESTIGATION AND DETERMINE IF ANY CORRECTIVE ACTION IS INDICATED.

    Description of Event or Problem · 1

    AFTER MAKING THE INITIAL INCISION, THE SURGEON VISUALIZED A SILVER COLORED RESIDUE AROUND THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168423 SURGICAL BLADE #15 IN CUSTOM PAK NONE GES ASPEN SURGICAL PRODUCTS, INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention