BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN STAPLER 35W

    MDR report key: 4752219 · Received May 5, 2015

    Report

    Report Number
    1060680-2015-00027
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    February 4, 2014
    Report Date
    May 1, 2015
    Manufacturer
    TELEFLEX MEDICAL DE MEXICO, S. DE R.I. DE C.V. AVE. INDUSTRIAS
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION FINDINGS: THE QFI REPORT WAS REVIEWED TO OBTAIN THE SALES AND SIMILAR COMPLAINT INFORMATION. DEROYAL HAS SOLD (B)(4) CASES OF THE FINISHED GOOD FROM 2012 TO 2014. THERE HAVE BEEN SIMILAR REPORTS IDENTIFIED FOR THE STAPLER "MISFIRING." THE PRODUCT WAS RECEIVED FROM TELEFLEX ON (B)(6) 2013 WITH A TOTAL OF (B)(4) CASES BEING RECEIVED UNDER PO (B)(4). (B)(4) HAS BEEN ISSUED TO THE VENDOR ON (B)(6) 2014. ADDITIONAL COMMUNICATION BETWEEN THE VENDOR AND THE QC COMPLAINT SPECIALIST OCCURRED. THE SCAR RESPONSE WAS RECEIVED ON (B)(6) 2014. AS PART OF THE SCAR RESPONSE, THE VENDOR HAS REFERENCED (B)(4) AND THE TESTING WITHIN THAT INVESTIGATION. BOTH THE SCAR AND TESTING ATTACHMENTS ARE INCLUDED WITHIN THIS COMPLAINT PACKET. CORRECTION: REPLACEMENTS HAVE BEEN PROVIDED. ROOT CAUSE ANALYSIS: THE DHR RECORDS AND COMPONENT INCOMING INSPECTION RECORDS FOR LOT 01D1300313 WERE REVIEWED. THERE HAVE BEEN NO NON-CONFORMANCES DISCOVERED. SAMPLES WERE EVALUATED OF THE PRODUCT PRODUCED AFTER THE LOT NUMBER WAS IDENTIFIED. NO ISSUES WERE FOUND. THE PRODUCT HAS PASSED ALL FUNCTIONALITY TESTING. THE RESULTS WERE SUBMITTED AS PART OF (B)(4). THE VENDOR IS UNABLE TO REPRODUCE THE REPORTED ISSUE DURING THE PRODUCT REVIEW. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: SCAR: A CORRECTIVE ACTION HAS NOT BEEN TAKEN. PREVENTIVE ACTION: SCAR: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THIS REPORT IS BEING FILED DUE TO A RETROSPECTIVE REVIEW OF COMPLAINTS. THIS COMPLAINT HAS BEEN RE-OPENED FOR FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF FURTHER INVESTIGATION PROVIDES INFORMATION WHICH CHANGES THE CONTENT OF THIS REPORT.

    Description of Event or Problem · 1

    THE STAPLE GUN MISFIRED OR NOT AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292741 SKIN STAPLER 35W STAPLE, REMOVABLE GDT TELEFLEX MEDICAL DE MEXICO, S. DE R.I. DE C.V. AVE. INDUSTRIAS 01D1300313

    Patients

    Seq Age Sex Outcome Treatment
    1