BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEROYAL SURGIMATE 35W 24/CASE

    MDR report key: 3231994 · Received July 15, 2013

    Report

    Report Number
    3003898360-2013-00291
    Event Type
    Malfunction
    Date Received
    July 15, 2013
    Date of Event
    May 6, 2013
    Report Date
    June 28, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GDT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE SAMPLE IS AVAILABLE FOR INVESTIGATION. PER DEVICE HISTORY REPORT (DHR) REVIEW INVESTIGATION DID NOT SHOW ISSUES RELATED TO THIS COMPLAINT. COMPLAINT CANNOT BE CONFIRMED SINCE THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION, THEREFORE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE DEFECT REPORTED AND A CORRECTIVE ACTION FOR IT. THE MFR WILL CONTINUE TO MONITOR AND TREND RELATING COMPLAINTS.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: COMPLAINT ALLEGES: THE CUSTOMER REPORTED THAT THE STAPLER JAMMED HALFWAY THROUGH THE USAGE OF THE DEVICE. NO PT INJURY. PT CURRENT CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325887 DEROYAL SURGIMATE 35W 24/CASE SKIN STAPLER GDT TELEFLEX MEDICAL 01C1300335

    Patients

    Seq Age Sex Outcome Treatment
    1