BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY

    MDR report key: 1446649 · Received August 24, 2009

    Report

    Report Number
    3005075853-2009-03361
    Event Type
    Malfunction
    Date Received
    August 24, 2009
    Date of Event
    May 14, 2009
    Report Date
    May 15, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K011501
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE STENT: 06/08/2009. NO BAG RETURNED. EVALUATION SUMMARY: THE POUCH DEVICE WAS RECEIVED IN GOOD CONDITION. THE DEVICE HAD BEEN FULLY DEPLOYED. THERE WAS NO BAG AND NO SUTURE RETURNED WITH THE DEVICE. THE SUPPORT ARMS WERE INSIDE THE TUBE ON ONE SIDE OF THE DISTAL PLUG. THE SUPPORT ARMS WERE ATTACHED TO THE PUSH-PULL ROD AND WERE IN GOOD CONDITION. THE SUPPORT ARM PIN WAS INTACT. THE DISTAL PLUG ASSEMBLY WAS IN GOOD CONDITION. THE REPORTED EVENT COULD NOT BE CONFIRMED AS THE BAG WAS NOT RETURNED FOR ANALYSIS. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. COMPLAINT INFO IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED, AND NO ANOMALIES WERE FOUND DURING THE MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE WHEN PULLING THE BAG OUT OF THE PORT, THE BAG RIPPED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GCJ LAPAROSCOPE, GENERAL AND PLASTIC SURGERY GCJ ETHICON ENDO-SURGERY, LLC NA F4NA4E

    Patients

    Seq Age Sex Outcome Treatment
    1