BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN STAPLER

    MDR report key: 10459409 · Received August 27, 2020

    Report

    Report Number
    1060680-2020-00001
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    July 30, 2020
    Report Date
    October 29, 2020
    Manufacturer
    DESIGN STANDARDS CORP.
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE PRODUCT IS SUPPLIED TO DEROYAL BY DESIGN STANDARDS CORP. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO DESIGN STANDARDS. IN ITS RESPONSE, THE SUPPLIER STATED THE RESULTS OF THE ROOT CAUSE ANALYSIS FOUND NO DEFECTS FOR THE FINISHED PRODUCT FROM THE REPORTED LOT. TWO DEVICES WERE RETURNED AND TESTED TO THE FINISHED PRODUCT TESTING STANDARD. THE DEVICES WERE FIRED IN AIR AND IN TEST MEDIA, AND NO DEFECTS WERE OBSERVED. THE ALLEGED DEFECTIVE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND THEREFORE, COULD NOT BE ANALYSED FOR THE DEFECT OBSERVED IN THE FIELD. THE POTENTIAL CAUSE FOR AN INCOMPLETE STAPLE FORMATION HAS BEEN OBSERVED WHEN THE DEVICE IS NOT USED AS DESCRIBED IN THE INSTRUCTIONS FOR USE. IF THE USER DOES NOT APPROXIMATE THE TISSUE USING FORCEPS AND PRESSES THE STAPLER INTO THE SKIN AND UNDERLYING HARD TISSUE OR BONE, THE STAPLE MAY NOT FORM COMPLETELY. CORRECTIVE ACTION: A CORRECTIVE ACTION HAS NOT BEEN TAKEN DUE TO THE ROOT CAUSE DETERMINATION. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED FOR A SKIN STAPLER THAT DID NOT CLOSE A SURGICAL WOUND. THREE PACKAGES OF SKIN STAPLERS WERE RETURNED FOR EVALUATION. THE COMPLAINT INVESTIGATOR OPENED ONE OF THESE PACKS AND ACTIVATED THE STAPLER INTO NEOPRENE FOAM. NO ISSUE WAS DETECTED, AND THE STAPLERS WORKED AS INTENDED. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE PRODUCT IS SUPPLIED TO DEROYAL BY DESIGN STANDARDS CORP. A SCAR WAS ISSUED TO THE SUPPLIER DUE TO THE NATURE OF THE EVENT. THE TWO ADDITIONAL PACKS OF STAPLES THAT WERE RETURNED BY THE CUSTOMER WERE SENT TO THE SUPPLIER FOR EVALUATION. A RESPONSE WAS RECEIVED AND ACCEPTED SEPTEMBER 11, 2020 BY DEROYAL PERSONNEL. SINCE JULY 2018, THERE HAVE BEEN (B)(4) CASES SOLD. THERE HAS BEEN ONE COMPLAINT IN THAT TIME FRAME, YIELDING A COMPLAINT-TO-SALES RATIO OF (B)(4). THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    A SKIN STAPLER WAS USED TO CLOSE A WOUND AFTER SURGERY. THE STAPLES DID NOT CLOSE THE WOUND.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY. AN INTERNAL COMPLAINT (CALL 50723) WAS RECEIVED FOR A SKIN STAPLER THAT DID NOT CLOSE A SURGICAL WOUND. THREE PACKAGES OF SKIN STAPLERS WERE RETURNED FOR EVALUATION. THE COMPLAINT INVESTIGATOR OPENED ONE OF THESE PACKS AND ACTIVATED THE STAPLER INTO NEOPRENE FOAM. NO ISSUE WAS DETECTED, AND THE STAPLERS WORKED AS INTENDED. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DISCREPANCIES WERE IDENTIFIED. THE PRODUCT IS SUPPLIED TO DEROYAL BY DESIGN STANDARDS CORP. A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO THE SUPPLIER DUE TO THE NATURE OF THE EVENT. THE TWO ADDITIONAL PACKS OF STAPLES THAT WERE RETURNED BY THE CUSTOMER WERE SENT TO THE SUPPLIER FOR EVALUATION. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. SINCE JULY 2018, THERE HAVE BEEN (B)(4) CASES SOLD. THERE HAS BEEN ONE COMPLAINT IN THAT TIME FRAME, YIELDING A COMPLAINT-TO-SALES RATIO OF (B)(4). THE INVESTIGATION IS INCOMPLETE AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    A SKIN STAPLER WAS USED TO CLOSE A WOUND AFTER SURGERY. THE STAPLES DID NOT CLOSE THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922909 SKIN STAPLER STAPLE, REMOVABLE (SKIN) GDT DESIGN STANDARDS CORP. 25-1001 NH180619-1

    Patients

    Seq Age Sex Outcome Treatment
    1