BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PWRD ECH FLEX 60MM

    MDR report key: 3193057 · Received June 27, 2013

    Report

    Report Number
    3005075853-2013-03315
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 10, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS FOUND THAT THE PSE60A DEVICE WAS RECEIVED WITH THE ANVIL DAMAGED AT KNIFE SLOT ARE AND WITH AN ECR60W CARTRIDGE LOADED ON THE DEVICE; THE RELOAD WAS NOTED TO BE PARTIALLY FIRED 1/2. IN ORDER TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS OF THE RELOAD IT WAS DISASSEMBLED AND THE RELOAD WAS NOTED TO HAVE THE DECK AND ONE PIECE SLED DAMAGED. THE DAMAGE TO THE CARTRIDGE IS CONSISTENT WITH THE DEVICE BEING CLAMPED OVER A HARD OBJECT. WHEN THIS HAPPENS THE CARTRIDGE GETS INDENTED THEREFORE THERE IS NOT ENOUGH SPACE FOR THE SLED PUSHING THE DRIVER TO CONTINUE ITS RUN, THIS IS THE REASON WHY THE SLED GETS DAMAGED. IF ENOUGH FORCE IS APPLIED TO THE FIRING TRIGGER THE ONE PIECE SLED CAN BREAK THROUGH THE CARTRIDGE RELOAD WALL ALLOWING THE FIRING TO CONTINUE. 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. IT SHOULD BE NOTED THAT IF RESISTANCE IS FELT DURING FIRING, THE FIRING SEQUENCE SHOULD BE STOPPED AND THE CARTRIDGE RELOAD SHOULD BE REPLACED. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE RETURNED CONDITION OF THE DEVICE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. THE ANALYSIS FOUND THAT ONE PSE60A DEVICE (B) WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE 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; NO ABNORMAL NOISE WAS NOTED. EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING. THE ANALYSIS FOUND THAT ONE PSE60A DEVICE (C) WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO CARTRIDGE 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; NO ABNORMAL NOISE WAS NOTED. EVENT COULD NOT BE CONFIRMED AS NO MALFORMED STAPLES WERE NOTED DURING FUNCTIONAL TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. : INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: FIRST FIRING ON WHAT TISSUE TYPE WAS THE DEVICE USED? KIDNEY AT WHAT LOCATION ON THE TISSUE? RENAL ARTERY OR VEIN. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ON WHICH FIRING(S) DID THIS EVENT OCCUR ? 1ST. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NA. WAS BUTTRESSING MATERIAL UTILIZED? NO. IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? CLIPS WERE PRESENT IN THE FIRING AREA. WERE ANY UNEXPECTED NOISES HEARD? YES. IF SO, WHEN? FROM THE BEGINNING OF THE PROCEDURE WHEN GOING THROUGH THE VESSEL NO METALLIC SOUND WAS HEARD THE BATTERY APPEARED TO BE WORKING EXTRA HARD TO FIRE. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? REVERSE BUTTON WORK CORRECTLY. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HAND ASSISTED LAPAROSCOPIC NEPHRECTOMY PROCEDURE THE SURGEON WAS HANDED THE DEVICE FOR THE INITIAL FIRING. IT IS NOT KNOWN IF HE FIRED ACROSS THE RENAL ARTERY OR RENAL VEIN, DURING THE START OF THE FIRING HE HEARD A NOISE LIKE THE SOUND OF THE BLADE FIRING INTO SOMETHING VERY THICK. THEY REVERSED THE DEVICE TO REMOVE IT AND IT HAD PARTIALLY FIRED AND CUT. THE SURGEON STATED THERE WAS A HOLE AT THE FIRING SITE AND SOME BLEEDING. HE WAS ABLE TO REMOVE THE KIDNEY AND THEN SUTURE AT THE SITE TO COMPLETE THE PROCEDURE. THERE WERE NO BLOOD PRODUCTS GIVEN TO THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293693 PWRD ECH FLEX 60MM STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4CL8H

    Patients

    Seq Age Sex Outcome Treatment
    1 RELOAD: ECR60W