BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN STAPLER

    MDR report key: 9174582 · Received October 10, 2019

    Report

    Report Number
    1060680-2019-00009
    Event Type
    Malfunction
    Date Received
    October 10, 2019
    Date of Event
    August 7, 2019
    Report Date
    January 6, 2020
    Manufacturer
    DESIGN STANDARDS CORP.
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE STAPLER 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 NO DEFECTS WERE OBSERVED IN THE FINISHED PRODUCT. SIX DEVICES WERE RETURNED AND TESTED ACCORDING TO THE FINISHED PRODUCT TESTING STANDARD. THE POTENTIAL ROOT 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: IN ITS SCAR RESPONSE, DESIGN STANDARDS INDICATED NO CORRECTIVE ACTION IS REQUIRED. NO DEFECTS WERE OBSERVED IN THE DEVICES RETURNED. INVESTIGATION SUMMARY AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED FOR A SKIN STAPLER (FINISHED GOOD 25-1001, LOT NH180619-1) THAT MALFUNCTIONED DURING USE. SPECIFICALLY, THE STAPLES DID NOT DEPLOY CORRECTLY INTO THE SKIN. ONE SIDE OF THE STAPLE WOULD NOT SECURE ITSELF INTO THE SKIN. THE DEFECTIVE SAMPLE WAS RETURNED TO DEROYAL FOR EVALUATION. ONE SAMPLE OUT OF THE LOT RETURNED WAS CONTAMINATED. THIS SAMPLE WAS EVALUATED AND FIRED WHEN ACTIVATED. TWO ADDITIONAL SAMPLES ALSO WERE EVALUATED AND FIRED WHEN ACTIVATED. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE IDENTIFIED. STOCK WAS CHECKED AND FOUND TO BE ACCEPTABLE. THE STAPLER IS SUPPLIED TO DEROYAL BY DESIGN STANDARDS CORP. THE 2018-2019 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR REPORTED EVENTS. NO SIMILAR EVENTS WERE IDENTIFIED. HOWEVER, DUE TO THE NATURE OF THE REPORTED FAILURE, A SCAR WAS ISSUED TO DESIGN STANDARDS. ADDITIONALLY, A BOX OF THE REPRESENTED LOT WAS RETURNED TO THE SUPPLIER FOR EVALUATION. A RESPONSE WAS RECEIVED AND ACCEPTED BY DEROYAL PERSONNEL ON OCTOBER 23, 2019. (B)(4). THE INVESTIGATION IS COMPLETE. IF NEW AND CRITICAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    STAPLES WOULD NOT COMPLETELY CLOSE WHEN DEPLOYED INTO THE SKIN. ONE SIDE WOULD NOT SECURE ITSELF INTO SKIN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY AN INTERNAL COMPLAINT ((B)(4)) WAS RECEIVED FOR A SKIN STAPLER (FINISHED GOOD 25-1001, LOT NH180619-1) THAT MALFUNCTIONED DURING USE. SPECIFICALLY, THE STAPLES DID NOT DEPLOY CORRECTLY INTO THE SKIN. ONE SIDE OF THE STAPLE WOULD NOT SECURE ITSELF INTO THE SKIN. THE DEFECTIVE SAMPLE WAS RETURNED TO DEROYAL FOR EVALUATION. ONE SAMPLE OUT OF THE LOT RETURNED WAS CONTAMINATED. THIS SAMPLE WAS EVALUATED AND FIRED WHEN ACTIVATED. TWO ADDITIONAL SAMPLES ALSO WERE EVALUATED AND FIRED WHEN ACTIVATED. THE WORK ORDER WAS REVIEWED FOR DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. NO DISCREPANCIES WERE IDENTIFIED. STOCK WAS CHECKED AND FOUND TO BE ACCEPTABLE. THE STAPLER IS SUPPLIED TO DEROYAL BY DESIGN STANDARDS CORP. THE 2018-2019 SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) AND SUPPLIER NOTIFICATION LETTER LOGS WERE REVIEWED FOR SIMILAR REPORTED EVENTS. NO SIMILAR EVENTS WERE IDENTIFIED. HOWEVER, DUE TO THE NATURE OF THE REPORTED FAILURE, A SCAR WAS ISSUED TO DESIGN STANDARDS. ADDITIONALLY, A BOX OF THE REPRESENTED LOT WAS RETURNED TO THE SUPPLIER FOR EVALUATION. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. FROM JANUARY 2017 TO PRESENT, (B)(4) UNITS OF THE REPORTED FINISHED GOOD HAVE BEEN SOLD. THERE HAS BEEN ONE COMPLAINT DURING THIS TIMEFRAME, YIELDING A COMPLAINT-TO-SALES RATIO OF (B)(4). THE INVESTIGATION IS ONGOING. WHEN NEW AND CRITICAL INFORMATION IS AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    STAPLES WOULD NOT COMPLETELY CLOSE WHEN DEPLOYED INTO THE SKIN. ONE SIDE WOULD NOT SECURE ITSELF INTO SKIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    968341 SKIN STAPLER STAPLE, REMOVABLE (SKIN) GDT DESIGN STANDARDS CORP. 25-1001 NH180619-1

    Patients

    Seq Age Sex Outcome Treatment
    1