BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PWRD ECH FLEX

    MDR report key: 3020668 · Received March 26, 2013

    Report

    Report Number
    3005075853-2013-01400
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS FOUND THAT ONE PLE60A DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH AN ECR60T RELOAD PRESENT. THE RELOAD WAS NOTED TO BE WITH THE RIGHT SIDE FULLY FIRED AND LEFT SIDE PARTIALLY FIRED. UPON EVALUATION OF THE RELOAD, THE CARTRIDGE BODY, SOME DRIVERS AND ONE PIECE SLED WERE NOTED TO BE DAMAGED. PLEASE NOTE AN INVESTIGATION HAS BEEN INITIATED TO ADDRESS THE POTENTIAL ROOT CAUSE FOR THE DAMAGE OF THE ONE PIECE SLED. AS ADDITIONAL TESTING, 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 AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORM SHAPE.

    Additional Manufacturer Narrative · 1

    (B)(4). ON WHICH FIRING DID THE EVENT OCCUR? FIFTH. WHERE WAS THE LOCATION OF THE MALFORMED STAPLES DISTAL, PROXIMAL OR IN THE MIDDLE OF THE STAPLE LINE? MIDDLE TO PROXIMAL ON THE PATIENT SIDE. WHERE THE MALFORMED STAPLES ON THE LINE CLOSEST TO THE CUT LINE OR IN ALL OF THE ROWS? CLOSEST TWO ROWS TO STAPLE LINE. WHAT WAS THE APPEARANCE OF THE MALFORMED STAPLES (WERE THE LEGS STRAIGHT OR DID THEY HAVE AN IRREGULAR FORM)? STRAIGHT. WHAT COLOR CARTRIDGE WAS BEING USED? BLACK. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? THREE GREEN AND 1 BLACK. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? SEAMGUARD BY GORE TOP AND BOTTOM. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO, HOWEVER FROM REVIEWING THE VIDEO THEIR APPEARS TO BE SUTURE REMNANTS VISIBLE. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO ALL APPEARED AS NORMAL. 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? TISSUE APPEARED STUCK TO THE PATIENT SIDE AND HAD TO BE SLIDE OUT WITH CARE. PLEASE EXPLAIN FOR CLARIFICATION WHAT IS MEANT BY, THE SURGEON HAD TO "OVER THROUGH" AND CHECK FOR LEAKS. OVER THROUGH SHOULD BE 'OVERSEW' SUTURING INTRACORPOREALLY OVER THE STAPLE LINE. CHECK FOR LEAKS USING A SOLUTION PLACED ORALLY AGAINST A AQUEOUS ENVIRONMENT ABDOMINALLY CHECKING FOR BUBBLES AND COLOURING. WAS A LEAK CONFIRMED? NO. IF A LEAK WAS CONFIRMED, HOW WAS IT RESOLVED? DID THE PROLONGED PROCEDURE TIME IMPACT THE PATIENT CLINICALLY? PATIENT IS STILL IN HOSPITAL TODAY. NO OTHER DETAILS KNOWN. HOW WAS THE CASE COMPLETED? ANOTHER GREEN FIRING WAS USED, SURGEON OVERSEWED MALFORMED STAPLE LINE AND CHECKED FOR LEAKAGE. PHOTOGRAPHS FROM THE EVENT WERE SUBMITTED FOR REVIEW. THE PHOTOGRAPHS CONFIRM THE EVENT DESCRIPTION RELATIVE TO MALFORMED STAPLES, SINCE IT APPEARS PROPER STAPLE DEPLOYMENT DID NOT OCCUR ON THE RIGHT SIDE OF THE STAPLE CARTRIDGE LOOKING PROXIMAL TO DISTAL. THE PLASTIC SEEN AT THE PROXIMAL END OF THE STAPLE CARTRIDGE WAS PROBABLY DISPLACED FROM THE DAMAGED AREA DURING THE KNIFE RETURN STROKE. BASED ON THE PHOTOGRAPHIC EVIDENCE PROVIDED IT IS BELIEVED THAT STAPLE DEPLOYMENT WHILE FIRING THE PLE60A DEVICE UTILIZING A BLACK STAPLE CARTRIDGE WAS DISRUPTED RESULTING IN MALFORMED STAPLES. THE PHOTOGRAPHS HOWEVER DO NOT PROVIDE ANY EVIDENCE TO WHAT MAY HAVE CAUSED THE DISRUPTED STAPLE DEPLOYMENT. HANDS ON ANALYSIS OF THE DEVICE IF RETURNED MAY PROVIDE THE INDICATORS NECESSARY TO DETERMINE THE CAUSE OF THE STAPLE DEPLOYMENT COMPLICATION. DEVICE IS ANTICIPATED TO BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, ON THE FINAL FIRING, THE STAPLER DEPLOYED AS NORMAL AND THE BLADE RETURNED AS NORMAL. UPON OPENING THE CARTRIDGE SOME STAPLES APPEARED NOT FORMED. THE SURGEON HAD TO "OVER THROUGH" AND CHECK FOR LEAKS. THE PROCEDURE WAS DELAYED FOR AN HOUR. UNKNOWN HOW CASE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124031 PWRD ECH FLEX STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK K4C19U

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention RELOAD-ECR60T LOT: J4CR2H, ECR60G