BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON FLEX60 LINEAR CUTTER

    MDR report key: 4840204 · Received June 12, 2015

    Report

    Report Number
    3005075853-2015-03535
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 23, 2015
    Report Date
    May 25, 2015
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BATCH # M5288P. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT TROUBLESHOOTING STEPS WERE ATTEMPTED TO OPEN THE DEVICE AFTER THE FOURTH FIRING? -USED MANUAL KNIFE REVERSE SWITCH BUT FAILED. DID THE JAWS OF THE DEVICE EVENTUALLY OPEN TO RELEASE THE TISSUE? -NO. WAS THE DEVICE FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? -UNK. IS THE B12LT TROCAR STILL ATTACHED TO THE EC60A? -NO. IF NO, WHY IS THE TROCAR BEING RETURNED? -THE ARTICULATING COULD NOT RESUME STRAIGHT DURING THE PROCEDURE. SO THE DEVICE WAS REMOVED WITH THE TROCAR. IT COULD NOT BE USED AGAIN. WHAT EMERGENCY MEASURES WERE USED TO FIX THE ANASTOMOSIS, INCLUDING THE AREAS OF THE MALFORMED STAPLES? -HAND SEWING. WAS THE PROCEDURE CONVERTED TO OPEN? -NO. WAS THERE ANY PATIENT CONSEQUENCE AS A RESULT OF THE PROCEDURE BEING PROLONGED? -NOT REPORTED. WAS A COLOSTOMY PERFORMED? -NO. IF YES, WAS THE COLOSTOMY PLANNED? -NA. WAS A LEAK TEST PERFORMED? -UNK. IF YES, WHAT WAS THE RESULT? -NA. DID THE PATIENT RECEIVE ANY NEOADJUVANT TREATMENTS (RADIATION, ETC.) PRIOR TO THE PROCEDURE? - UNK. WAS THERE ANY CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT? -NO. THE ANALYSIS FOUND THAT ONE EC60A DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS AND WITH FOUR ECR60D CARTRIDGE RELOADS PRESENT. CARTRIDGE (B, C) ECR60D, L54G4M WERE RECEIVED FULLY FIRED AND IN GOOD VISUAL CONDITIONS. CARTRIDGE (D) ECR60D, L54G4M WERE RECEIVED FULLY FIRED AND WITH CARTRIDGE DECK DAMAGE. THE FOUND DAMAGE ON THE DECK (D) IS CONSISTENT WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE; WHEN THIS HAPPENS THE KNIFE PLOWS THE STAPLES ON CARTRIDGE DECK AND SHAVING MAY OCCUR. TO MITIGATE THE POTENTIAL FOR STAPLES GETTING INTO THE CARTRIDGE AND INTERFERING WITH THE KNIFE PATH DURING DEVICE FIRING, 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. 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. CARTRIDGE (E) ECR60D, L54M4P WAS RECEIVED FULLY FIRED AND WITH CARTRIDGE DECK DAMAGE. THE DAMAGE TO THE CARTRIDGE (E) IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. THE DEVICE WAS TESTED FOR FUNCTIONALITY IN THE ARTICULATED 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. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEEN PARTIALLY FIRED OR FULLY FIRED A REVERSE STROKE NEEDS TO BE PERFORMED TRIGGER TO TRIGGER TO HANDLE IN ORDER TO RETURN THE KNIFE TO THE HOME POSITION (INDICATOR IN THE "0" POSITION) AND PRESS THE ANVIL RELEASE BUTTON TO OPEN. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. IT IS POSSIBLE THAT THE DEVICE WAS CLAMPED OVER AN EXCESS OF TISSUE CAUSING THE ANVIL TO BENT AND FOR THE FIRING STROKE AND THE STAPLE LINE TO BE INCOMPLETE. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE CONTACT. INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. 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. WHAT TROUBLESHOOTING STEPS WERE ATTEMPTED TO OPEN THE DEVICE AFTER THE FOURTH FIRING? DID THE JAWS OF THE DEVICE EVENTUALLY OPEN TO RELEASE THE TISSUE? WAS THE DEVICE FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? WHAT EMERGENCY MEASURES WERE USED TO FIX THE ANASTOMOSIS, INCLUDING THE AREAS OF THE MALFORMED STAPLES? WAS THE PROCEDURE CONVERTED TO OPEN? WAS THERE ANY PATIENT CONSEQUENCE AS A RESULT OF THE PROCEDURE BEING PROLONGED? WAS A COLOSTOMY PERFORMED? IF YES, WAS THE COLOSTOMY PLANNED? WAS A LEAK TEST PERFORMED? IF YES, WHAT WAS THE RESULT? DID THE PATIENT RECEIVE ANY NEOADJUVANT TREATMENTS (RADIATION, ETC.) PRIOR TO THE PROCEDURE? WAS THERE ANY CHANGE IN THE POST-OPERATIVE CARE OF THE PATIENT AS A RESULT OF THE EVENT?

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC RADICAL RESECTION OF RECTAL CARCINOMA PROCEDURE, AFTER REMOVING THE EC60A FROM THE PACKAGE, IT WAS FOUND THAT THE JAWS OF THE DEVICE WERE NOT COMPLETELY OPEN. THE SURGEON USED THE DEVICE WITH ECR60D TO TRANSECT THE TISSUE. THE TISSUE WAS CUT AND STAPLES WERE MALFORMED AFTER THE FIRST THREE FIRINGS. THE JAW COULD NOT OPEN AFTER THE 4TH FIRING. THE MANUAL KNIFE REVERSE SWITCH DIDN¿T WORK. THE SURGEON USED HIGH FORCE TO REMOVE THE EC60A WITH THE TROCAR FROM THE PATIENT¿S BODY. TOOK EMERGENCY MEASURES TO FIX THE ANASTOMOSIS AND USED NEW DEVICES TO COMPLETE THE SURGERY. THE OPERATION WAS PROLONGED MORE THAN 2 HOURS. THE PATIENT IS IN STABLE CONDITION NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384592 ECHELON FLEX60 LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA M9084A

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD ECR60D, L4F84H, L4FA83