BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKIN STAPLER 35W

    MDR report key: 4752220 · Received May 5, 2015

    Report

    Report Number
    1060680-2015-00026
    Event Type
    Malfunction
    Date Received
    May 5, 2015
    Date of Event
    January 30, 2014
    Report Date
    May 1, 2015
    Manufacturer
    MODERN MEDICAL EQUIPMENT MFG, LTD.
    Product Code
    GDT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) CASES OF THE FINISHED GOOD FROM 2012 TO 2013. THERE HAVE BEEN SIMILAR REPORTS IN WHICH THE PRODUCT HAS JAMMED DURING USE. (B)(4) HAS BEEN ISSUED TO (B)(4). THE VENDOR HAS RESPONDED TO THE SCAR. WITHIN THE SCAR, IT IS REFERENCED TO (B)(4). THIS SCAR ALSO HAS BEEN ATTACHED WITHIN THE COMPLAINT INVESTIGATION. THE LOT NUMBER IDENTIFIED WAS MANUFACTURED PRIOR TO THE ACTIONS IMPLEMENTED. CORRECTION: AS PER THE CUSTOMER'S REQUEST, A REPLACEMENT HAS BEEN SHIPPED IN ORDER# (B)(4). ROOT CAUSE ANALYSIS: SCAR: IT IS SUSPECTED THE STAPLER HAD CAUGHT HOLD OF TWO OR MORE STAPLES IN A FIRING DUE TO LOWER HARDNESS OF THE PUSHING PLATE COMPONENT. THEREFORE, THE STAPLE WAS NOT PUSHED OUT FROM THE CARTRIDGE IN THE CORRECT POSITION, WHICH CAUSED MECHANICAL JAMMING. CORRECTIVE ACTION AND/OR SYSTEMIC CORRECTION ACTION TAKEN: SCAR: BASED ON THE FAILURE MODE AND SYMPTOM, WE HAD ALREADY DONE NECESSARY PRECAUTION ON THE PUSHING PLATE COMPONENT TO INCREASE THE HARDNESS OF THE COMPONENT FROM LOT #130703009 WITH HARDNESS 350 +/- 20 HV (1.0) INSTEAD OF 310 HV (1.0). FOR CORRECTIVE ACTIONS, REFER TO (B)(4). 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

    FOUR STAPLERS JAMMED AND WERE DISCARDED DUE TO BLOOD ON THE STAPLER. SURGERY WAS DELAYED WHILE NEW STAPLER WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295554 SKIN STAPLER 35W DISPOSABLE SKIN STAPLER GDT MODERN MEDICAL EQUIPMENT MFG, LTD. 1030303038

    Patients

    Seq Age Sex Outcome Treatment
    1