BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVIDIEN (FORMERLY TYCO)

    MDR report key: 2003211 · Received February 15, 2011

    Report

    Report Number
    2003211
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 31, 2011
    Report Date
    February 14, 2011
    Manufacturer
    COVIDIEN
    Product Code
    GAT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ADMITTED AND UNDERWENT ELECTIVE VAGINAL HYSTERECTOMY, RT. OOPHORECTOMY, RT ANTERIOR COLPOPERINEORRHAPHY, ANTERIOR REPAIR, POSTERIOR REPAIR, RECTOCELE & ENTEROCELE REPAIR. FOLLOWING ATTEMPTED SACROSPINOUS LIGAMENT FIXATION ( WE SUSPECT DEVICE MALFUNCTION), THE NEEDLE WAS IMMEDIATELY NOTED TO BE MISSING FROM THE ENDOSTITCH HANDLE. THE SURGEON MANUALLY RETRIEVED THE NEEDLE, BUT A 2MM PIECE (THE TIP OF THE NEEDLE) HAD BROKEN OFF, REMAINING IN THE PT-DEEMED BY THE SURGEON TO BE IRRETRIEVABLE. ATTEMPT WAS MADE TO RELOAD NEEDLE CARTRIDGE INTO THE ENDOSTITCH HANDLE (#1) BUT FAILED, AS THE DEVICE WOULD NOT TOGGLE THE CARTRIDGE FROM SIDE TO SIDE. A SECOND ENDOSTITCH (#2) WAS OPENED, LOADED WITH CARTRIDGE, AND NEEDLE DEPLOYED BY SURGEON. REMOVAL OF ENDOSTITCH DEVICE REVEALED THE NEEDLE TO BE IN PLACE (IN CARTRIDGE LOADED INTO DEVICE), HOWEVER THE TIP OF THE NEEDLE WAS MISSING. SEARCH OF THE AREA, AS WELL AS SURGEON PALPATION OF CAVITY, DID NOT FIND THE MISSING TIP OF THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COVIDIEN (FORMERLY TYCO) 10 MM SHORT ENDOSTITCH (FIRST DEVICE) GAT COVIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR