BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN STAPLER, 35W

    MDR report key: 10657629 · Received October 9, 2020

    Report

    Report Number
    1060680-2020-00003
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 2, 2020
    Report Date
    November 16, 2020
    Manufacturer
    MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
    Product Code
    GAG
    UDI-DI
    50749756677610
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ROOT CAUSE: THE SUPPLIER IS SUPPLIED TO DEROYAL BY MODERN MEDICAL. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO MODERN MEDICAL. IN ITS RESPONSE, THE SUPPLIER STATED RETAINED SAMPLES OF THE REPORTED LOT WERE CHECKED. THESE SAMPLES PERFORMED CORRECTLY DURING A FIRING TEST AND SIMULATED TEST ON PIG SKIN. A DEVICE HISTORY RECORD REVIEW ALSO WAS PERFORMED. THE INVESTIGATION FOUND NO NON-CONFORMITIES. BASED ON THE INVESTIGATION, MODERN MEDICAL BELIEVES THIS WAS AN ISOLATED INCIDENT. THE PROBABLE ROOT CAUSE MAY BE THAT THE STAPLE WAS NOT CAUGHT WELL DURING THE FIRING PROCESS, WHICH COULD BE CONFIRMED BY CHECKING THE DEFECTIVE SAMPLE. CORRECTIVE ACTION: DUE TO THE ROOT CAUSE DETERMINATION, A CORRECTIVE ACTION HAS NOT BEEN TAKEN. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT: (B)(4) WAS RECEIVED FOR A SKIN STAPLER (PART: 25-3001C) THAT MALFUNCTIONED DURING USE. SPECIFICALLY, THE STAPLER WAS NOT FULLY FORMING STAPLES. THE CUSTOMER RETURNED SAMPLES FROM THE SAME LOT WERE RETURNED FOR EVALUATION. THE SAMPLE RETURNED WAS NOT THE ACTUAL DEFECTIVE SAMPLE, WHICH WAS DISCARDED DUE TO CONTAMINATION. (B)(4). INVENTORY WAS CHECKED AND SHOWED NO DISCREPANCIES. STOCK WAS CHECKED BY FIRING SKIN STAPLES INTO NEOPRENE FOAM. ALL RESULTS WERE ACCEPTABLE. THE STAPLER IS SUPPLIED TO DEROYAL BY MODERN MEDICAL MANUFACTURING. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO MODERN MEDICAL AS WELL AS THE RETURNED SAMPLE. THE SUPPLIER'S RESPONSE WAS RECEIVED OCTOBER 8 AND APPROVED BY DEROYAL PERSONNEL OCTOBER 9. 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 PHYSICIAN WAS USING A SKIN STAPLER TO CLOSE A WOUND AND NEEDED 25-30 STAPLES. WHEN USING THE PRODUCT, HE SAID THE RIGHT SIDE OF THE STAPLE WOULD NOT CRIMP. FOUR STAPLERS WERE REQUIRED TO GET WHAT HE NEEDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED FOR A SKIN STAPLER (PART 25-3001C) THAT MALFUNCTIONED DURING USE. SPECIFICALLY, THE STAPLER WAS NOT FULLY FORMING STAPLES. SINCE AUGUST 2018, (B)(4) UNITS HAVE BEEN SOLD. THERE HAVE BEEN 2 COMPLAINTS DURING THIS TIMEFRAME, YIELDING A COMPLAINT-TO-SALES RATIO OF (B)(4). NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED DURING THIS TIMEFRAME. INVENTORY WAS CHECKED AND SHOWED NO DISCREPANCIES. STOCK WAS CHECKED BY FIRING SKIN STAPLES INTO NEOPRENE FOAM. ALL RESULTS WERE ACCEPTABLE. THE STAPLER IS SUPPLIED TO DEROYAL BY MODERN MEDICAL MANUFACTURING. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST WAS ISSUED TO MODERN MEDICAL. AS OF THE DATE OF THIS REPORT, A RESPONSE HAS NOT BEEN RECEIVED. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    A PHYSICIAN WAS USING A SKIN STAPLER TO CLOSE A WOUND AND NEEDED 25-30 STAPLES. WHEN USING THE PRODUCT, HE SAID THE RIGHT SIDE OF THE STAPLE WOULD NOT CRIMP. FOUR STAPLERS WERE REQUIRED TO GET WHAT HE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123487 SKIN STAPLER, 35W STAPLER, SURGICAL GAG MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. 25-3001C 200506005 50749756677610

    Patients

    Seq Age Sex Outcome Treatment
    1