BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURVED CIRCULAR STAPLER 25 MM

    MDR report key: 1971848 · Received January 27, 2011

    Report

    Report Number
    3005075853-2011-00326
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 6, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011: THE FIRING OCCURRED IMMEDIATELY AFTER PURSE-STRING SUTURE CLAMP WAS DONE. SURGEON DID NOT HEAR A SOUND TACKLE FEEDBACK AFTER COMPLETE P TO P FIRING. HE WITHDREW THE DEVICE, DISASSEMBLED IT BUT FOUND THE STAPLE BEEN PULLED OUT WITHOUT STAPLE B FORMATION (STILL IN ORIGINAL SHAPE), THE WASHER HAD NOT BEEN CUT. ANASTOMOSIS COMPLETED BY HAND SUTURE EVENTUALLY. REP RESTORED IT FROM THE OR, FIRED TWICE THEN THE WASHER WAS CUT. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. PER ADDITIONAL NOTES ATTACHED TO THE COMPLAINT FILE, THE WASHER WAS NOT CUT DURING THE PROCEDURE BUT AFTERWARDS OUTSIDE THE PATIENT BY THE SALES REPRESENTATIVE PERFORMING A DRY FIRE. AN UNCUT WASHER IS CONSISTENT WITH THE DEVICE NOT BEING FIRED THROUGH A FULL FIRING STROKE OR POSSIBLY THAT THE GREEN INDICATOR WAS NOT FULLY INTO THE SAFE FIRING RANGE. IT SHOULD BE NOTED THAT BEFORE FIRING THE DEVICE, THE GREEN INDICATOR SHOULD BE FULLY WITHIN THE GAP SETTING WINDOW. THE TRIGGER SAFETY MUST REMAIN IN THE "LOCKED" POSITION UNTIL THE SURGEON HAS CONFIRMED THE INDICATOR IS IN RANGE AND THEY ARE READY TO FIRE THE DEVICE. AFTER THE TRIGGER SAFETY IS RELEASED, THE DEVICE CAN BE FIRED WITHOUT BEING "IN RANGE," POTENTIALLY RESULTING IN THE DEVICE BEING UNABLE TO PROPERLY FORM STAPLES OR CUT. IN ADDITION, IT SHOULD BE NOTED THAT IF THE FIRING SEQUENCE IS NOT COMPLETE (PLASTIC TO PLASTIC) STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE BATCH RECORDS WERE REVIEWED AND THE FINAL QUALITY RELEASE CRITERIA WERE MET BEFORE THE BATCHES WERE RELEASED FOR DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLES WERE MALFORMED AND THE DEVICE COULD NOT CUT THE TISSUE. THE SURGEON USED HAND SEWING TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURVED CIRCULAR STAPLER 25 MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4TG68

    Patients

    Seq Age Sex Outcome Treatment
    1