BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHELON*FLEX45 COMPACT

    MDR report key: 2181796 · Received July 27, 2011

    Report

    Report Number
    3005075853-2011-03044
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 8, 2011
    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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. KNIFE WING AND ANVIL. THE ANALYSIS RESULTS FOUND THAT ONE SC45A DEVICE WAS RETURNED WITH THE ANVIL BENT UPWARDS, AND WITH THE THREE POINT GAP CONTROL DAMAGED. NO CARTRIDGE RELOAD WAS RECEIVED FOR ANALYSIS. THE DAMAGE TO THE ANVIL AND THE THREE POINT GAP CONTROL IS CONSISTENT WITH THE DEVICE BEING CLAMPED AND FIRE OVER AN EXCESS OF TISSUE. THIS WILL RESULT IN THE OVERSTRESS OF THE ANVIL AND THREE GAP CONTROL ATTEMPTING TO APPROXIMATE THE ANVIL TO THE CARTRIDGE RELOAD FOR A CONSISTENT STAPLE FORMATION GAP. IF ENOUGH FORCE IS EXERTED IN THE FIRING TRIGGER IT WILL RESULT IN THE DAMAGE OBSERVED TO THE ANVIL, THE THREE POINT GAP CONTROL AND FOR THE FIRING STROKE TO BE INCOMPLETE AND THE DEVICE TO LOCK OUT. IT SHOULD BE NOTED THAT IN ORDER TO OPEN A DEVICE THAT HAS BEING 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. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE DEVICE. IT SHOULD BE NOTED THAT A 100% INSPECTIONS TAKES PLACE DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRE SPECIFICATIONS PRIOR TO SHIPMENTS, (B)(4). 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 TOTAL VAGINAL HYSTERECTOMY PROCEDURE, THE DEVICE WAS FIRED AND THERE WAS A CRUNCH NOISE BETWEEN THE FIRST AND SECOND STROKE. THEN THE DEVICE WOULD NOT OPEN. THE TISSUE AROUND THE JAWS HAD TO BE CUT TO REMOVE THE DEVICE THEN THE TISSUE WAS TIED OFF WITH SUTURE. SUTURE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES REPORTED. ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? SIDE OF THE UTERUS. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ASKU. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? 1ST OR SECOND STROKE. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? WHITE. WAS BUTTRESSING MATERIAL UTILIZED? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? ASKU. WERE ANY UNEXPECTED NOISES HEARD? CRUNCHING NOISE. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES WOULD NOT OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX45 COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK NI

    Patients

    Seq Age Sex Outcome Treatment
    1