BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSL ACCESS SYSTEM

    MDR report key: 1914128 · Received December 3, 2010

    Report

    Report Number
    3005075853-2010-06836
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 9, 2010
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE DEVICE DEVELOPED A TEAR. A PIECE OF THE DEVICE FELL INTO THE PATIENT BUT WAS ABLE TO BE RETRIEVED THROUGH THE INCISION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CUSTOMER WILL NOT RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SSL ACCESS SYSTEM GENERAL & PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4RD4X

    Patients

    Seq Age Sex Outcome Treatment
    1