BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2945207 · Received February 6, 2013

    Report

    Report Number
    3005075853-2013-00497
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 14, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED ANVIL. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? STOMACH AT WHAT LOCATION ON THE TISSUE? JEJUNUM. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ASKU. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? ASKU. WHAT COLOR CARTRIDGE WAS BEING USED? BLACK. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? ASKU. WAS BUTTRESSING MATERIAL UTILIZED? NO IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ASKU. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. THE ANALYSIS RESULTS FOUND THAT ONE DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITH SIX RELOADS PRESENT. THE RELOADS WERE RECEIVED FULLY FIRED AND IN GOOD CONDITION. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE STRAIGHT POSITION WITH A TEST CARTRIDGE RELOAD AND ACHIEVED ITS COMPLETE FIRING SEQUENCE WITHOUT ANY DIFFICULTIES. THE STAPLE LINE AND CUT LINE WERE COMPLETE; HOWEVER, THE MOST DISTAL STAPLES DID NOT FORM COMPLETELY DUE TO THE DAMAGE ON THE ANVIL. IT IS KNOWN FROM THE HISTORY OF THE DEVICE THAT THE CONDITION OF THE ANVIL MAY LEAD THAT THE MOST DISTAL STAPLES NOT TO FORM PROPERLY. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BENT AND FOR THE FIRING STROKE AND THE STAPLE FORM TO BE INCOMPLETE. IN ADDITION, THE CUT WAS NOTED TO BE JAGGED DUE TO A DAMAGED KNIFE. ONE POSSIBLE CAUSE FOR THIS TYPE OF DAMAGE TO THE KNIFE IS WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE, HARD OBJECT OR THICKER TISSUE THAN INDICATED. REPEATEDLY FIRING ACROSS EXISTING STAPLE LINES CAN ALSO REDUCE THE ABILITY TO CUT CLEANLY. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, PRIOR TO RELOADING THE DEVICE, RINSE THE ANVIL AND CARTRIDGE JAW IN STERILE SOLUTION AND THEN WIPE THE ANVIL AND CARTRIDGE JAW TO CLEAN ANY FORMED BUT UNUSED STAPLES FROM THE DEVICE. ADDITIONALLY, PROPER CARE SHOULD BE TAKEN WHEN PLACING THE DEVICE ON THE TISSUE TO BE STAPLED, TO ENSURE THAT NO HARD OBSTRUCTION SUCH AS A CLIP IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, IN ADDITION, A SAMPLE OF THE BATCH IS INSPECTED AT FGQA. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. A SURGICAL PHOTOGRAPH WAS RECEIVED AND IT IS BELIEVED THE COMPLICATION WAS THE RESULT OF DECK DEFLECTION BECAUSE THE COMBINED THICKNESS OF TISSUE AND BUTTRESSING WAS BEYOND THE DEVICES ABILITY TO BRING THE TISSUE INTO THICKNESS COMPLIANCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A BARIATRIC PROCEDURE THE SURGEON FIRED THREE SEPARATE BLACK RELOADS AND NOTICED THAT THE STAPLES WERE MALFORMED. WHEN HE OBSERVED THE STAPLE LINES HE SAW THAT EACH OF THE THREE FIRINGS HAD INCOMPLETE STAPLE LINES IN THE CENTER AND APPEARED THAT THE STAPLES HAD NOT STRUCK THE ANVIL OF THE DEVICE DURING THE FIRINGS. HE THEN USED THE SAME DEVICE WITH ADDITIONAL RELOADS AND COMPLETED THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50532 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD: ECR60T