BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN STAPLER 35W, FIXED HEAD

    MDR report key: 4758436 · Received May 5, 2015

    Report

    Report Number
    1060680-2015-00035
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    February 6, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG, LTD.
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    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) OF THE FINISHED GOOD FROM 2012 TO 2014. THERE BEEN ISSUES PREVIOUSLY IDENTIFIED FOR THE PRODUCT. (B)(4) HAS BEEN ISSUED TO THE VENDOR, (B)(4). THE SAMPLE AND LOT NUMBER WERE NOT PROVIDED BY THE REPORTING CUSTOMER; THEREFORE, THE VENDOR CONDUCTED TESTING UTILIZING RETENTION SAMPLES OF A LOT NUMBER THAT WAS AVAILABLE WITHIN THEIR INVENTORY. THE TESTED SAMPLE PASSED FUNCTIONALITY TESTING AND IS PROVIDED WITHIN THE SCAR RESPONSE. CORRECTION: A CORRECTION HAS NOT BEEN TAKEN. ROOT CAUSE ANALYSIS: SCAR: WE HAD TESTED THE RETAINED SAMPLES OF THE LOT NUMBER 130903003, WHICH RECENTLY SHIPPED ON 11/18/2013 AND FOUND THAT THEY FUNCTIONED CORRECTLY. AS WE CANNOT OBTAIN THE DEFECTIVE SAMPLES FOR THOSE COMPLAINTS, WE CANNOT GO INTO MORE DETAILED ANALYSIS BY OBTAINING THE RESPONSIBLE OPERATOR, PRODUCTION TIME, AND EQUIPMENT STATUS RECORDS, ETC. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: SCAR: AT THE MOMENT, CONTINUOUS PRODUCTION STATUS OBSERVATION IS NEEDED. 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

    STAPLER JAMS. (B)(6) HOSPITAL, IS RECEIVING THE 25-3001CNS SKIN STAPLER INSIDE A CUSTOM PACK THEY RECEIVED FROM CARDINAL (ENDO AAA PACK). NO LOT NUMBER IS AVAILABLE BECAUSE IT IS COMING TO THEM INSIDE A PACK. THE CLINICIANS REFUSE TO USE THIS STAPLER ANYMORE. DOCTORS SAY THERE ARE MULTIPLE ISSUES OCCURRING ON A REGULAR BASIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294738 SKIN STAPLER 35W, FIXED HEAD DISPOSABLE SKIN STAPLER GDT MODERN MEDICAL EQUIPMENT MFG, LTD. NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1