BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE ILS CURVED CIR STAPL

    MDR report key: 3033564 · Received April 3, 2013

    Report

    Report Number
    3005075853-2013-01572
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNCUT WASHER - UNBLEMISHED. THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION VOID OF STAPLES AND WITH THE BREAKAWAY WASHER UNCUT, INDICATING THAT THE DEVICE HAD NOT BEEN FIRED THROUGH A FULL FIRING STROKE, THE ORANGE INDICATOR WAS NOT FULLY INTO THE SAFE GREEN FIRING RANGE OR THE ANVIL WAS NOT REATTACHED CORRECTLY. IT SHOULD BE NOTED THAT BEFORE FIRING, ENSURE THAT THE ORANGE INDICATOR IS FULLY WITHIN THE GREEN RANGE OF THE GAP SETTING SCALE AND THE ANVIL IS REATTACHED CORRECTLY. TO REATTACH THE DETACHABLE HEAD OR ANVIL DO NOT CLAMP ACROSS OR GRIP ON THE LOCKING SPRINGS AS IT MIGHT NOT CLICK INTO PLACE. NOT REATTACHING THE ANVIL CORRECTLY OR THE ORANGE INDICATOR NOT BEING SET ON THE GREEN RANGE WILL RESULT IN A BIGGER GAP BETWEEN THE ANVIL AND THE GUIDE FACE, THEREFORE THE STAPLES WILL NOT HIT THE ANVIL TO MAKE B- FORMED STAPLES. IN ADDITION IF THE FIRING SEQUENCE IS NOT COMPLETE, STAPLES COULD BE PARTIALLY DEPLOYED WITHOUT CUTTING THE WASHER. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE DEVICE WAS RELOADED WITH STAPLES AND TESTED FOR FUNCTIONALITY; THE DEVICE 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. IT SHOULD BE NOTED THAT TO REMOVE THE DEVICE AFTER A COMPLETE FIRING STROKE, OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS. TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. PLEASE REFERENCE THE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION. THE MANUFACTURING RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LOW ANTERIOR RESECTION PROCEDURE, THE SURGEON REPORTED HEARING THE CRUNCH UPON FIRING THE STAPLER. WHE ATTEMPTING TO REMOVE THE DEVICE IT WAS DIFFICULT TO REMOVE AND WAS 'STUCK' EVEN AFTER OPENING THE STAPLER ½ TO ¾ TURNS. AFTER MULTIPLE ATTEMPTS TO REMOVE, THE ANASTAMOSIS TORE AND DEVICE WAS STILL STUCK ON TISSUE. THE ENTIRE ANASTAMOSIS HAD TO BE CUT OUT ALONG WITH THE STAPLER AND A HAND SEWN ANASTAMOSIS. UPON EXAMINATION, THERE SEEMED TO BE NO CUT ON THE POSTERIOR SIDE OF THE ANASTAMOSIS, WHILE THE ANTERIOR SIDE APPEARED TO BE CUT. THERE WERE SOME MALFORMED STAPLES. BEING A LOW RESECTION (AROUND 4CM) AN APR WAS AVOIDED. THERE WERE NO PATIENT CONSEQUENCES. THE CASE WAS DELAYED BY 180 MINUTES. THE PROLONGED PROCEDURE DID NOT CHANGE THE POST-OPERATIVE CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136970 PROXIMATE ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1