BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX 60 ENDO

    MDR report key: 2043253 · Received April 7, 2011

    Report

    Report Number
    3005075853-2011-01393
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT THE LTS60A DEVICE WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH NO RELOAD PRESENT. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED ALL THE STAPLES AS INTENDED; HOWEVER, THE CUT WAS JAGGED DUE TO A DAMAGED KNIFE. ONE POSSIBLE CAUSE FOR THE DAMAGED KNIFE MAY BE IF 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, 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 IS ALSO RECOMMENDED THAT 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. ALTHOUGH NO CONCLUSION COULD BE REACH ON WHAT CAUSED THE REPORTED EVENT, IT SHOULD BE NOTED THAT ALL DEVICES ARE INSPECTED 100% FOR STAPLE PRESENCE BY AN (B)(4), AND ARE VISUALLY INSPECTED 100% AS A FINAL CHECK. IN ADDITION, AT FINISHED GOODS THE DEVICES ARE VISUALLY INSPECTED BASED ON A SAMPLE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BY PASS PROCEDURE THE SURGEON FIRED THE DEVICE WITH A BLUE RELOAD FOR THE SECOND FIRING. WHEN SHE OBSERVED THE STAPLE LINE THERE WERE MALFORMED STAPLES AND THE STAPLE LINE OPEN UP AND WAS INCOMPLETE. THE SURGEON THEN STITCHED OVER THE STAPLELINE AND USED ANOTHER DEVICE TO CREATE THE POUCH. THEY THEN OVER SEWED THE ENTIRE ANASTOMOSIS AND PERFORMED A LEAK TEST. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX 60 ENDO STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1