BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOUTHMEDIC SPSS CARTRIDGE

    MDR report key: 2594422 · Received November 15, 2010

    Report

    Report Number
    8022032-2010-00001
    Event Type
    Malfunction
    Date Received
    November 15, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 10, 2010
    Manufacturer
    SOUTHMEDIC, INC.
    Product Code
    GES
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF BATCH RECORD AND MFG PROCESS FOR ROOT CAUSE OF FAILURE. INSPECTION OF STOCK AND IN PROCESS INVENTORY FOR SUBSTANTIATION OF COMPLAINT.

    Description of Event or Problem · 1

    DURING THE USE OF A SAFETY SCALPEL BLADE CARTRIDGE; A PORTION OF THE PLASTIC SHEATH SEPARATED FROM THE DEVICE AND FELL INTO THE WOUND. THE INCIDENT OCCURRED DURING A SURGICAL PROCEDURE ON THE KNEE. THE CARTRIDGE WAS LOADED ONTO THE HANDLE, THE SAFETY TAB WAS PULLED AWAY. THE SAFETY SHEATH WAS PULLED BACK AND THE SCALPEL WAS HANDED TO THE SURGEON WITHOUT INCIDENT. WHEN THE SURGEON PRESSED THE BLADE AGAINST THE MENISCUS TISSUE, THE CARTRIDGE SEPARATED AND ONE HALF OF THE CARTRIDGE FELL INTO THE SURGICAL WOUND. THE BREAKAGE OF THE DEVICE AND THE PIECE THAT FELL INTO THE WOUND WAS IMMEDIATELY SEEN BY THE SURGICAL STAFF AND THE BROKEN PIECE WAS RETRIEVED FROM THE SURGICAL SITE USING FORCEPS. THE SUSPECT DEVICE WAS THE SECOND OF THREE DEVICES USED IN THE PROCEDURE. THE FIRST AND THIRD DEVICE WERE USED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOUTHMEDIC SPSS CARTRIDGE DISPOSABLE SAFETY SCALPEL CARTRIDGE GES SOUTHMEDIC, INC. 73-8015 080310.1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention