BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EEA

    MDR report key: 8802720 · Received July 18, 2019

    Report

    Report Number
    2647580-2019-03732
    Event Type
    Malfunction
    Date Received
    July 18, 2019
    Date of Event
    June 13, 2019
    Report Date
    November 20, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    20884523005537
    PMA / PMN Number
    K062850
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE VISUAL INSPECTION OF THE STAPLE GUIDE NOTED THE INSTRUMENT WAS FULLY APPLIED. THE ANVIL OF THE INSTRUMENT WAS OBSERVED TO BE TILTED AND ATTACHED TO THE INSTRUMENT. HOWEVER, ONE OF THE RETAINER LEGS OF THE ANVIL WAS OBSERVED TO BE BENT. FUNCTIONALLY, A PMV REPRESENTATIVE ANVIL WAS USED FOR FIRING DUE TO THE OBSERVED RETAINER LEG DAMAGE OF THE CLINICAL ANVIL. THE DEVICE WAS APPLIED OVER THE APPROPRIATE TEST MEDIA PRODUCING ACCEPTABLE RESULTS. THE KNIFE CUT THE TEST MEDIA CLEANLY AND COMPLETELY AND THE PUSHERS ADVANCED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE OBSERVED ANVIL DAMAGE MAY OCCUR IF THE ANVIL IS MANIPULATED WITH EXCESSIVE FORCE DURING THE ATTACHMENT TO THE INSTRUMENT, OR IF THE ANVIL IS MISHANDLED DURING THE REMOVAL OF FITTING ACCESSORIES. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A COLORECTAL SURGERY, WHILE DOING A SURGICAL STAPLING, IT WAS NOTED THAT THE ANVIL OF THE DEVICE WAS BENT AND IT PARTIALLY FIRED. THE SURGEON OPENED ANOTHER STAPLER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597314 EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EEA28 P8H1614KX 20884523005537

    Patients

    Seq Age Sex Outcome Treatment
    1