BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS FLEX ARTICNG LNR CUTR

    MDR report key: 3142510 · Received June 3, 2013

    Report

    Report Number
    3005075853-2013-02732
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 5, 2013
    Report Date
    May 13, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2013. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ON WHICH FIRING DID THE EVENT OCCUR? WHAT COLOR CARTRIDGE WAS BEING USED? WAS THE CARTRIDGE RETRIEVED FROM THE PATIENT? HOW WAS THE CARTRIDGE REMOVED?

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE SURGEON WAS USING THE DEVICE ON AN APPENDECTOMY. AT THE END OF THE CASE, THE SURGEON WAS LOOKING AT THE PERITONEAL CAVITY AND THE SURGEON DISCOVERED THE STAPLE CARTRIDGE HAD COME LOOSE AND WAS IN THE BELLY. THERE WERE NO PATIENT CONSEQUENCES. CASE WAS ALREADY COMPLETED, SO ANOTHER DEVICE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245105 ETS FLEX ARTICNG LNR CUTR STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CG9H

    Patients

    Seq Age Sex Outcome Treatment
    1