BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSCOPIC LINEAR CUTTER

    MDR report key: 1895487 · Received November 10, 2010

    Report

    Report Number
    3005075853-2010-06412
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Report Date
    October 18, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS SHOWED THAT THE TSB35 DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. THE CARTRIDGE WAS RECEIVED PARTIALLY FIRED AND WITH THE CARTRIDGE LOCK OUT TAB NORMAL. AFTER FURTHER EVALUATION IT WAS NOTED THAT THERE WAS DAMAGE ON THE CARTRIDGE PAN SURFACE. THE DAMAGE TO THE CARTRIDGE PAN IS CONSISTENT WITH AN IMPROPER OR INCOMPLETE LOADING/SEATING OF THE CARTRIDGE. IF THE CARTRIDGE IS NOT FULLY INSERTED/SEATED INTO THE CHANNEL, THE RETENTION FEATURES ON THE CARTRIDGE ARE NOT ENGAGED TO THE CHANNEL WINDOWS OF THE DEVICE. AT FIRING THE DEVICE WILL PUSH THE CARTRIDGE FORWARD RESULTING IN THE PAN TO PARTIALLY OR COMPLETELY DISLODGE. IT SHOULD BE NOTED THAT 100% INSPECTION TAKES PLACE DURING MANUFACTURING TO ENSURE THAT THE CARTRIDGES ARE LOADED CORRECTLY. THE RETURNED DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST CARTRIDGE AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTE TO HAVE THE PROPER B-FORMED SHAPE. THE RELOAD WAS LOADED AND DID NOT FELL OUT DURING FUNCTIONAL TESTING. ALTHOUGH NO CONCLUSION COULD BE REACHED AS TO HOW THE CARTRIDGE WAS NOT PROPERLY SEATED BEFORE THE DEVICE WAS FIRED, IT IS POSSIBLE THAT WHILE MANIPULATING THE DEVICES INTO THE TISSUE TO BE STAPLED THE MOST DISTAL PART OF THE CARTRIDGE ENCOUNTERED AN UPWARD FORCE EITHER FROM CONTACT WITH ANOTHER DEVICE, SOLID STRUCTURE OR AN ORGAN RESULTING IN THE CARTRIDGE TO PARTIALLY DISENGAGE FROM THE CHANNEL. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE MAGAZINE FELL INTO PIECES, EVERYTHING COULD BE REMOVED. NO FURTHER INFORMATION IS AVAILABLE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOSCOPIC LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1