BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1527736-2010-00060

    MDR report key: 1841057 · Received September 22, 2010

    Report

    Report Number
    1527736-2010-00060
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    GCJ
    PMA / PMN Number
    K032676
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICES RETURNED DISASSEMBLED AFTER THE RECEIPT OF THE DEVICES AND IT WAS IDENTIFIED THAT ONLY SEVEN SEALS WERE RETURNED WITH TWO TROCARS (SHOULD HAVE BEEN 8 SEALS; 4 FOR EACH TROCAR), THE CUSTOMER WAS CONTACTED TO CONFIRM IF THE PIECE HAD BEEN RETRIEVED FROM THE PATIENT. THE CUSTOMER INDICATED SHE IS POSITIVE THE PIECE WAS RETRIEVED FROM THE PATIENT AND IT WAS DISCARDED DURING THE CASE. DEVICE (A) WAS RECEIVED WITH THE DUCKBILL OUT OF ITS INTENDED POSITION AND MISSING. FURTHER EVALUATION FOUND THE SCRAPPER WAS TORN, THE LOWER RING WAS MISSING, THE UPPER RING WAS DAMAGED AND THE BLACK SEALS WERE DETACHED AND DAMAGED. DUE TO THE RETURNED CONDITION OF THE DEVICE, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE SEAL ISSUES. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. DEVICE (B) WAS RECEIVED WITH THE DUCKBILL OUT OF ITS INTENDED POSITION AND MISSING. FURTHER EVALUATION FOUND THE SCRAPPER WAS TORN, THE LOWER RING WAS MISSING, THE UPPER RING WAS DAMAGED AND THE BLACK SEALS WERE DETACHED. DUE TO THE RETURNED CONDITION OF THE DEVICE, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE SEAL ISSUES. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. IT IS EVIDENT THAT THE DEVICES WERE TAKEN APART AS INDICATED IN THE CUSTOMER'S REPORT. DETERMINATION OF A ROOT CAUSE PERTAINING TO THE DISLODGEMENT AND COMPLETE DETACHMENT OF THE SEAL COMPONENT CANNOT BE REACHED. AS THE OBTURATOR WAS NOT RECEIVED AND IT IS THE PART THAT HAS THE BATCH STAMPED, WE DID NOT RECEIVE A BATCH OR LOT NUMBER FOR THE PRODUCT INVOLVED IN THIS COMPLAINT. THEREFORE, WE WERE UNABLE TO CHECK MANUFACTURING RECORDS FOR ANY RELATED NON-CONFORMANCES.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCJ ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1