BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SSL ACCESS SYSTEM

    MDR report key: 1832975 · Received September 14, 2010

    Report

    Report Number
    3005075853-2010-05245
    Event Type
    Malfunction
    Date Received
    September 14, 2010
    Date of Event
    August 8, 2010
    Report Date
    August 19, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER SEVERAL REQUESTS, THE DEVICE WAS NOT RECEIVED FOR ANALYSIS.

    Description of Event or Problem · 1

    THE SALES REP REPORTS THAT DURING A LSO PROCEDURE, THE DEVICE TORE DURING INSERTION. THEY USED A TROCAR TO COMPLETE. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SSL ACCESS SYSTEM GENERAL & PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC. NA G4R76P

    Patients

    Seq Age Sex Outcome Treatment
    1