BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPOSE

    MDR report key: 3800015 · Received April 23, 2014

    Report

    Report Number
    3800015
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    April 2, 2014
    Report Date
    April 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT EXCISION AND PRIMARY CLOSURE OF THE BASAL CELL CARCINOMA OF THE LEFT PARIETAL SCALP, EXCISIONAL BIOPSY OF RIGHT PINNA LESION, AND CO2 LASER ABLATION OF MULTIPLE ACTINIC KERATOSIS OF LEFT MALAR EMINENCE. DURING THE SURGERY, THE STAPLER WAS BEING USED WHEN IT LOCKED UP AND WOULD STICK DURING USE. A SECOND STAPLER WAS THEN USED AND HAD THE SAME ISSUE. BOTH STAPLERS HAD SAME LOT AND REFERENCE NUMBERS. THERE WAS NO DELAY OR HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245109 APPOSE STAPLE, REMOVABLE (SKIN) GDT COVIDIEN * J3K02031X

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR OCCURRED DURING SURGERY