BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN STAPLER, 35W, FIXED HEAD

    MDR report key: 6027652 · Received October 13, 2016

    Report

    Report Number
    1060680-2016-00029
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    August 31, 2016
    Report Date
    January 4, 2017
    Manufacturer
    MODERN MEDICAL EQUIPMENT MANUFACTURING LTD.
    Product Code
    GAG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL COMPLAINT CALL (B)(4) WAS RECEIVED INDICATING A SKIN STAPLER FINISHED GOOD (B)(6) WAS NOT FUNCTIONING PROPERLY. THE END USER REPORTED THE STAPLES WOULD NOT COME OUT, AND WHEN THEY DID, THE STAPLES WERE NOT "CRIMPING ENOUGH TO HOLD." THE INITIAL REPORTER STATED THE SAMPLE WAS AVAILABLE FOR RETURN. HOWEVER, THE SAMPLE HAS NOT BEEN RETURNED AS OF THE DATE OF THIS REPORT. THE DEVICE IS SUPPLIED TO DEROYAL BY MODERN MEDICAL EQUIPMENT. THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SUBMITTED TO MODERN MEDICAL. INTERNAL COMPLAINTS WERE REVIEWED FOR THE PERIOD OF 2014 TO PRESENT. FOUR SIMILAR COMPLAINTS OF THE STAPLER JAMMING OR FAILURE TO PROPERLY FUNCTION WERE IDENTIFIED FOR THE REPORTED FINISHED GOOD. THE INVESTIGATION IS ONGOING AT THIS TIME. WHEN NEW AND CRITICAL INFORMATION IS AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ROOT CAUSE ANALYSIS: THE STAPLER IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) WAS ISSUED TO (B)(4). IN ITS RESPONSE, (B)(4) INDICATED IT WAS UNABLE TO IDENTIFY THE FAILURE. THE SAMPLE WAS RETURNED AND EVALUATED WITH 27 UNUSED STAPLES. THE STAPLES WERE FOUND TO OPERATE NORMALLY AND ACCORDING TO SPECIFICATION. CORRECTIVE ACTION: IN ITS SCAR RESPONSE, (B)(4) INDICATED A CORRECTIVE ACTION HAS NOT BEEN TAKEN. IT WILL CONTINUE TO MONITOR THE REPORTED ISSUE. INVESTIGATION SUMMARY: AN INTERNAL COMPLAINT (CALL (B)(4)) WAS RECEIVED INDICATING A SKIN STAPLER (FINISHED GOOD 25-3001CNS) WAS NOT FUNCTIONING PROPERLY. THE END USER REPORTED THE STAPLES WOULD NOT COME OUT, AND WHEN THEY DID, THE STAPLES WERE NOT "CRIMPING ENOUGH TO HOLD." THE INITIAL REPORTER STATED THE SAMPLE WAS AVAILABLE FOR RETURN. THE SAMPLE WAS RECEIVED AND FORWARDED DECEMBER 12, 2016, TO THE SUPPLIER FOR EVALUATION. THE DEVICE IS SUPPLIED TO DEROYAL BY (B)(4). THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST (SCAR) HAS BEEN SUBMITTED TO (B)(4). AN INITIAL RESPONSE WAS RECEIVED OCTOBER 31, 2016; HOWEVER, THAT RESPONSE WAS UPDATED DECEMBER 29, 2016, FOLLOWING EVALUATION OF THE RETURNED SAMPLE. DEROYAL QUALITY PERSONNEL HAS REVIEWED AND ACCEPTED THESE RESPONSES. IN ITS INITIAL SCAR RESPONSE, (B)(4) STATED IT CONDUCTED A DEVICE HISTORY RECORD REVIEW FOR PRODUCT MANUFACTURED OVER A THREE-MONTH PERIOD AND FOUND NO NON-CONFORMITIES. INTERNAL COMPLAINTS WERE REVIEWED FOR THE PERIOD OF 2014 TO PRESENT. (B)(4) SIMILAR COMPLAINTS OF THE STAPLER JAMMING OR FAILURE TO PROPERLY FUNCTION WERE IDENTIFIED FOR THE REPORTED FINISHED GOOD. PREVENTIVE ACTION: A PREVENTIVE ACTION HAS NOT BEEN TAKEN. THE INVESTIGATION IS COMPLETE AT THIS TIME. IF NEW AND CRITICAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE STAPLER IS NOT FUNCTIONING PROPERLY. CUSTOMER STATES THE STAPLE WON'T COME OUT, AND WHEN THE STAPLE DOES COME OUT, IT IS NOT CRIMPING ENOUGH TO HOLD.

    Description of Event or Problem · 1

    THE STAPLER IS NOT FUNCTIONING PROPERLY. CUSTOMER STATES THE STAPLE WON'T COME OUT, AND WHEN THE STAPLE DOES COME OUT, IT IS NOT CRIMPING ENOUGH TO HOLD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678356 SKIN STAPLER, 35W, FIXED HEAD STAPLER, SURGICAL GAG MODERN MEDICAL EQUIPMENT MANUFACTURING LTD. 25-3001CNS NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1