BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON 60 ENDOPATH

    MDR report key: 2872069 · Received December 13, 2012

    Report

    Report Number
    3005075853-2012-05680
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 28, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). JAMMED KNIFE. THE DEVICE WAS RETURNED WITH THE CLOSING TRIGGER AND ANVIL CLOSED. A RELOAD WAS RECEIVED LOADED ON THE DEVICE AND FULLY FIRED. UPON FURTHER INSPECTION OF THE DEVICE, A CLIP WAS FOUND LODGED IN THE CARTRIDGE KNIFE SLOT PREVENTING THE KNIFE FROM RETURNING COMPLETELY AND THE ANVIL FROM OPENING. WHEN PLACING THE INSTRUMENT ON THE TISSUE TO BE STAPLED, ENSURE THAT NO HARD OBSTRUCTION (SUCH AS A CLIP) IS INCLUDED WITH THE TISSUE INSIDE THE JAWS. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR WARNINGS AND PRECAUTION REGARDING FIRING ACROSS HARD OBJECTS. THE CLIP WAS REMOVED AND THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD; THE DEVICE ACHIEVED A COMPLETE 3-STROKES FIRE WITHOUT ANY DIFFICULTIES NOTED. THE DEVICE OPENED AND CLOSED AS INTENDED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE NOT RETURNED. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ONCE DEVICE WAS REMOVED, HAD ANY STAPLES BEEN DEPLOYED? WERE THE DEPLOYED STAPLES COMPLETELY FORMED? DID THE DEVICE FULLY CUT THE TISSUE? WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, OR FIRING)? ONCE THE DEVICE WAS REMOVED WAS THERE DAMAGE TO THE TISSUE? HOW WAS IT REPAIRED? IS THERE ANY OTHER ADDITIONAL INFORMATION YOU WOULD LIKE TO SHARE ABOUT THIS DEVICE OR PROCEDURE?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE DEVICE WOULD NOT OPEN. AFTER THE FIRST CUT OF THE STOMACH WITH A CARTRIDGE, WHEN OPENING THE DEVICE, IT REMAINED CLOSED. THE SURGEON WAS ABLE TO REMOVE THE DEVICE GENTLY WITH PLIERS "COELIO". ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON 60 ENDOPATH STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA J4CE9J

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD-ECR60B