BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETS-FLEX - ENDOSCOPIC

    MDR report key: 1884596 · Received October 28, 2010

    Report

    Report Number
    3005075853-2010-05970
    Event Type
    Malfunction
    Date Received
    October 28, 2010
    Date of Event
    September 22, 2010
    Report Date
    September 24, 2010
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE (B)(4) DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE RELOAD WAS LOADED ON THE DEVICE WITHOUT ANY DIFFICULTIES NOTED AND DID NOT FELL OUT. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS NO CARTRIDGE WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    OUR SALES REP IS REPORTING THAT A PT HAD AN ACL PROCEDURE DONE ON (B)(6) 2010 USING AN 8-10MM X 30MM BIO-INTRAFIX SCREW AND LARGE BIO-INTRAFIX SHEATH. AT SOME POINT AFTER THE ORIGINAL DATE OF SURGERY THE PT EXPERIENCED SITE TENDERNESS, AND DIAGNOSTIC TESTS REVEALED A WIDENING OF THE TUNNEL IN THE AREA OF THE BIO-INTRAFIX SCREW AND SHEATH. AN INTERVENTION PROCEDURE WAS DONE ON THE PT ON (B)(6) 2010 TO FLUSH OUT THE AREA OF THE BIO-INTRAFIX SCREW AND SHEATH, FOR WHAT THE SURGEON REFERRED TO AS A REACTION. IT IS UNK AT THIS TIME IF THE BIO-INTRAFIX SCREW AND SHEATH WERE REMOVED FROM THE PT. INITIAL CULTURE RESULTS REVEALED THERE WAS NO GROWTH TO INDICATE AN INFECTION AT THIS TIME. FURTHER CULTURE TESTING IS BEING PERFORMED. THE PT HAD THEIR DRESSING CHANGED ON (B)(6) 2010 AND WAS REPORTED TO BE DOING FINE AT THAT TIME. SEE ASSOCIATED MDR 1221934-2010-00386.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN APPENDECTOMY PROCEDURE, THE DEVICE WOULD CUT BUT STAPLED PARTIALLY. AT THE BEGINNING OF PROCEDURE, THE RELOAD INSIDE THE STAPLER SEEMED DISLODGED. THE DEVICE WAS USED BUT NOT AS INTENDED. BLEEDING OCCURRED. NO TRANSFUSION NEEDED. THEY USED ANOTHER LIKE DEVICE TO CONTINUE WITH NO ISSUE TO THE PT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETS-FLEX - ENDOSCOPIC GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC NA G4T916

    Patients

    Seq Age Sex Outcome Treatment
    1