BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EEA

    MDR report key: 7142093 · Received December 22, 2017

    Report

    Report Number
    1219930-2017-10363
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 1, 2016
    Report Date
    December 22, 2017
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE ATTACHED COMPLAINT FORM WAS SUBMITTED TO RA ON THE (B)(6). THE EVENT DATE IS THE (B)(6) AND THE PRODUCT SPECIALIST WAS AWARE ON THE (B)(6). THE PRODUCT SPECIALIST IS CALLING TO THE ACCOUNT TODAY AND WILL HAVE ADDITIONAL INFORMATION ON THE COMPLAINT AND SAMPLE AND THE UDI NUMBER. THE REPORTED ISSUE IS AS FOLLOWS "(B)(6) USED THE EEA GUN BACK IN (B)(6) AND SAID THE GUN DID NOT CLICK WHEN HE OPENED THE GUN AFTER FIRING (B)(4). HE THOUGHT HE MAY HAVE MISSED THIS BUT IT HAS HAPPENED AGAIN RECENTLY TO HIMSELF AND A COLLEAGUE AND WOULD LIKE THE GUN TO BE LOOKED AT. HE HAS USED THIS GUN FOR MANY YEARS AND SAID THIS HAS NEVER HAPPENED BEFORE AND FINDS IT VERY UNNERVING THAT THE GUN IS NOT CLICKING. THE DOUGHNUTS WERE FINE AFTER FIRING AND THE PATIENT HAS GONE HOME WITHOUT ANY ISSUES AT THE MOMENT." THE PRODUCT IS BEING RETURNED. THE PRODUCT WAS NOT RESTERILIZED PRIOR TO USE. THE COMPLAINT PRODUCT WAS USED ON A PATIENT. THE FOLLOWING INFORMATION WAS ALSO PROVIDED IN RELATION TO THIS COMPLAINT: PERSON INJURED OR JEOPARDIZED: NO EXTENSION OF THE SURGERY TIME BY MORE THAN 30 MINUTES OR RE-OPERATION NECESSARY: NO BLOOD LOSS OF MORE THAN 500CC: NO EXTENSION OF THE INCISION BY MORE THAN 1 INCH: NO CHANGE FROM ENDOSCOPIC TO OPEN SURGERY: NO UNANTICIPATED TISSUE LOSS OR IRREVERSIBLE DAMAGE: NO ANY PORTION OF THE DEVICE OR TACK FALL INTO THE PATIENT CAVITY: NO IF YES WERE THE PIECES /TRACKS RETRIEVED FROM THE PATIENT: NO WAS ANY REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE? NO HOW WAS THE ISSUE SOLVED: THE DOUGHNUTS WERE FINE AFTER FIRING AND THE PATIENT HAS GONE HOME WITHOUT ANY ISSUE AT THE MOMENT - NO ACTION NEEDED. ADDITIONAL INFORMATION REQUESTED VIA EMAIL TO (B)(4). PLEASE HAVE THE REP SUBMIT A FTR FOR THE INCIDENT THAT OCCURRED IN MAY. CAN YOU CONFIRM THAT PRODUCT IS AVAILABLE AND WILL BE RETURNED FOR EVALUATION? WHAT IS THE PRODUCT ID AND LOT NUMBER FOR THE HANDLE USED WITH THIS RELOAD? COULD YOU PLEASE PROVIDE THE UDI# (SEE ATTACHED, RED BOX) FOR THE HANDLE USED IN THE PROCEDURE? WHAT IS THE PRODUCT ID AND LOT NUMBER FOR THE RELOAD USED WITH THIS STAPLER? COULD YOU PLEASE PROVIDE THE UDI# (SEE ATTACHED, RED BOX) FOR THE RELOAD USED IN THE PROCEDURE? WAS ANY REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE? IF YES, WHAT WAS THE BRAND OF THE REINFORCEMENT MATERIAL USED? WHAT SURGICAL PROCEDURE WAS BEING PERFORMED? WHAT IS THE PATIENT AGE, WEIGHT, GENDER, RACE, ETHNICITY, OR PATIENT IDENTIFIER (I.E. INITIALS OR ID NUMBER, NOT THE FULL NAME OF THE PATIENT)?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921879 EEA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EEA28 P6B0380KX

    Patients

    Seq Age Sex Outcome Treatment
    1