BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE

    MDR report key: 1942974 · Received December 22, 2010

    Report

    Report Number
    1942974
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 21, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ETHICON
    Product Code
    GDW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHILE RE-LOADING THE GIA 75 STAPLER, TECH WAS CHECKING TO MAKE SURE STAPLE WAS SEATED PROPERLY AND FELT SOMETHING SHARP AND NOTICED THAT THERE WERE STAPLES STICKING OUT OF HER GLOVE AND CHECKED THE STAPLE CARTRIDGE AND NOTICED MORE STAPLES WERE STICKING OUT OF THE CARTRIDGE. BOTH SETS OF GLOVES WERE PUNCTURED AND SHE NOTICED BLEEDING FROM PUNCTURE SITE. ANOTHER STAPLE CARTRIDGE WAS OBTAINED AND USED WITHOUT INCIDENT. THE ABOVE MENTIONED CARTRIDGE WAS NOT USED ON PT. THE STAPLER, HOWEVER, HAD BEEN USED ON PT PRIOR TO TRYING THIS CARTRIDGE. SCRUB TECH WAS RELOADING A GIA 75 STAPLER AND FELT PAIN IN HER FINGER AND NOTED STAPLES WERE STICKING OUT OF FINGER AND CARTRIDGE. CARTRIDGE WAS REMOVED FROM STAPLER AND FIELD ANOTHER CARTRIDGE WAS OBTAINED AND INSERTED WITHOUT INCIDENT. THE FAULTY CARTRIDGE WAS NOT USED. LOADING PROCEDURE WAS FOLLOWED PROPERLY AND TESTING TO SEEING IF STAPLES SEATED PROPERLY. STAPLER WAS USED ON PATIENT PRIOR TO RELOAD AND POST INCIDENT (WITH NEW CARTRIDGE). TECHS GLOVES CONTAINED BLOOD FROM PT WHEN STAPLE PUNCTURED GLOVE AND TECH'S SKIN. RESULTING IN BLOOD EXPOSURE - MODERATE DEPTH PUNCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE LINEAR CULTER RELOAD (THICK) 75 MM GDW ETHICON TRT75 D4GM7G

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR