BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSL ACCESS SYSTEM

    MDR report key: 2200010 · Received August 10, 2011

    Report

    Report Number
    3005075853-2011-03246
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 19, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GCJ
    PMA / PMN Number
    K091211
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE AND RETRACTOR WERE RETURNED. THE LOWER (SMOOTH) RING OF THE RETRACTOR WAS NOT ATTACHED TO THE BODY OF THE RETRACTOR. NO ABNORMAL VISUAL FINDINGS WERE NOTED ON THE SEAL CAP. THE RETRACTOR WAS RETURNED TORN. DUE TO THE CONDITION OF THE RETURNED DEVICE NO FUNCTIONAL TESTING COULD BE PERFORMED. THE REPORTED INCIDENT WAS CONFIRMED HOWEVER HOW THE DAMAGE OCCURRED COULD NOT BE ASCERTAINED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AT THE END OF THE CASE, THE DEVICE TORE AND FELL APART INTO THE PATIENT. THE BOTTOM HALF WAS REMOVED THROUGH THE TROCAR. THEY HAD COMPLETED THE PROCEDURE AT THIS POINT. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SSL ACCESS SYSTEM GENERAL & PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1