BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3132285 · Received May 29, 2013

    Report

    Report Number
    3005075853-2013-02593
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 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). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT WAS THE APPEARANCE OF THE MALFORMED STAPLE (IRREGULAR SHAPE OR LEGS STRAIGHT)? A SHARP V SHAPE WITH ONE TIP SLIGHTLY BENT AWAY FROM THE V. WAS THE OOZING OF BLOOD JUST AT THE AREA WHERE THE MALFORMED STAPLE WAS? NO. - THE ENTIRE STAPLE LINE OOZED. HOW MUCH BLOOD WAS LOSS? MINIMAL. MINOR OOZING BUT COMBINED WITH THE MALFORMED STAPLE THE SURGEON WAS MORE COMFORTABLE CHANGING DEVICES. DID THE PATIENT REQUIRE A BLOOD TRANSFUSION? NO. WAS THE PATIENT ON ANTICOAGULATION THERAPY? NO. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? 2 WHITES WITH SYNOVIS BUTTRESSING. NO BUTTRESSING WAS USED FOR THE FIRING IN WHICH THERE WAS AN ISSUE. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES. THIS WAS THE FIRING ACROSS THE 'TOP' OF THE 'PANTS SEAM' IN A SIDE TO SIDE JJ ANASTOMOSIS. IF ANY UNEXPECTED NOISES WERE HEARD, WHEN WERE THEY HEARD? NONE. 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 FOUND THAT ONE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE RELOAD LOADED ON THE DEVICE. 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. EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ROUX EN Y GASTRIC BYPASS PROCEDURE, DURING THE THIRD FIRING OF THE DEVICE, THE SURGEON WAS COMPLETING THE JJ ANASTOMOSIS BY STAPLING ACROSS THE BP AND DISTAL LIMBS. THE SURGEON WAS USING A WHITE LOAD WITHOUT BUTTRESSING MATERIAL. FOLLOWING COMPLETION OF THE FIRING SEQUENCE, SOME OOZING WAS NOTICED AT THE STAPLE LINE AND A MALFORMED STAPLE WAS NOTED STICKING TO THE BOWEL. THE MALFORMED STAPLE WAS NOT PART OF THE FINAL STAPLE LINE AND DID NOT PENETRATE THE BOWEL; IT WAS SIMPLY SITTING ON TOP OF THE TISSUE. THE OOZING AND MALFORMED STAPLE CAUSED THE SURGEON TO PREFER OPENING ANOTHER DEVICE RATHER THAN CONTINUE WITH ONE HE WAS NOT 100% CONFIDENT IN. ANOTHER DEVICE WAS OPENED AND THE CASE COMPLETED. THERE WERE NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236309 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1