BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN SURGICAL PATTIE

    MDR report key: 4011132 · Received August 14, 2014

    Report

    Report Number
    1226348-2014-11898
    Event Type
    Injury
    Date Received
    August 14, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    HBA
    PMA / PMN Number
    PK880402
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING LOT TRAVELER WAS PULLED AND REVIEWED FOR LOT 481293. THE PRODUCT WAS PRODUCED IN MAY OF 2014. ALL INFORMATION ON THE TRAVELER INDICATES THAT THE PRODUCT WAS PRODUCED WITHIN SPECIFICATIONS. THERE WAS AN ENGINEERING CHANGE ORDERS BUT IT WAS FOR A GASKET CHANGE ON FORM FILL SEAL WHICH WOULD BE OF A UNRELATED PIECE OF EQUIPMENT. ALL PULL TESTS (WHICH ENSURE PROPER BOND BETWEEN THE STRING AND PATTIE) WERE REVIEWED AND FOUND TO BE WITHIN ACCEPTABLE LIMITS. THE MINIMUM PULL STRENGTH SPECIFICATION IS 2.0 LB AND THIS LOT, BUT THE ALERT LEVEL IS 3 LBS. ALL THE PULL TESTS RANGED FROM 3.4 LBS TO 7 LBS. THEREFORE ROOT CAUSE COULD NOT BE DETERMINED. IT LOOKS LIKE THE STRING WASN'T PRESENCE WHEN THE WELDER CAME DOWN TO WELD THE COMPONENTS TOGETHER. ALL THE OPERATORS ARE TRAINED TO INSPECT ALL THE PATTIES AND WRAP THEM ONTO THE CARD. IT SEEMS THAT THE OPERATOR MISSED THIS REJECT AND BECAUSE THERE WAS TEN PATTIES WITH STRING THE OPERATOR FULFILLED THE CARD REQUIREMENT OF HAVING TEN STRINGS PRESENT, BUT WITH ELEVEN PATTIES. THE MACHINE ALWAYS COUNTS OUT 10 PATTIES SO THE OPERATOR MUST OF MISSED THE FIRST CHECK PATTIE THAT THE MACHINE MAKES TO START THE PROCESS. THE SCENARIO ABOVE IS A VERY RARE OCCURRENCE. WE HAVE SEEN VERY FEW COMPLAINTS FOR THIS PARTICULAR FAILURE MODE. WE WILL CONTINUE TO MONITOR CUSTOMER COMPLAINTS TO ENSURE THIS IS NOT A DEVELOPING TREND WHICH WILL REQUIRE CORRECTIVE ACTION. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT: THERE IS A BOX OF PATTIES THAT CONTAIN AN EXTRA PATTIE WITH NO STRING ATTACHED. PRODUCT CODE 80-1403, LOT# 481293. (B)(6) 2014 THE CUSTOMER CALLED AND STATED THAT THERE WERE NO DELAYS IN SURGERY OR ADVERSE CONSEQUENCES TO THE PATIENT. NO PATIENT INFORMATION WAS PROVIDED AND THE PRODUCT WILL BE RETURNED FOR AN EVALUATION. (B)(6) 2014 THE RETURNED PATTY (WITH NO STRING ATTACHED) WAS SENT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485396 CODMAN SURGICAL PATTIE PADDIE, COTTONOID HBA CODMAN & SHURTLEFF, INC. 481293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention