BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 2941924 · Received February 4, 2013

    Report

    Report Number
    3005075853-2013-00448
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WAS DOES MACERATING TISSUE MEAN? JABBING TISSUE, PARTIAL CUT THE TISSUE. WAS TISSUE REPAIR NEEDED? YES. HOW WAS THE TISSUE REPAIRED? BY PULLING ANOTHER DEVICE WITH CUTTING AND STAPLING. WERE THE RELEASE STAPLES FORMED CORRECTLY? NOT FORMED CORRECTLY, MALFORMED AND OPEN LEGS. ON WHAT TISSUE TYPE WAS THE DEVICE USED? GASTRIC. AT WHAT LOCATION ON THE TISSUE? ANTRUM OF THE STOMACH. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC.)? SECOND OR 3RD FIRING. WHAT COLOR CARTRIDGE WAS BEING USED? GREEN. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? GREEN. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES, STAPLE LINES. WERE ANY UNEXPECTED NOISES HEARD? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO. IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE? WHEN THE DEVICE WAS FIRED THE TISSUE WAS BEING SUCKED INTO THE DEVICE. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). A PHOTOGRAPH WAS RECEIVED AND IT IS BELIEVED THAT TISSUE FLOW WAS THE CAUSE OF THE RESULTING STAPLE FORM AND CUTLINE. HOWEVER BASED ON THE PHOTOGRAPHIC EVIDENCE, THE PRIMARY CAUSE OF THE TISSUE FLOW COULD NOT BE DETERMINED .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE WAS RELEASING THE STAPLES BUT DID NOT CUT THE TISSUE. IT WAS MACERATING THE TISSUE. NO OTHER DETAILS OF THE EVENT ARE PRESENTLY KNOWN. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47323 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1