BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA MEDIUM/THICK RADIAL RELOAD

    MDR report key: 3800261 · Received April 30, 2014

    Report

    Report Number
    1219930-2014-00340
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
    Product Code
    GDW
    PMA / PMN Number
    K083519
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE: LOW ANTERIOR RESECTION. ACCORDING TO THE REPORTER: DISPOSABLE SURGICAL STAPLER. THE SURGEON PERFORMED THE LAPAROSCOPIC PORTION OF DISSECTING OUT THE SIGMOID AND RECTAL TISSUE AS WELL AS SKELENTIZING THE TISSUE FOR TRANSECTION. HE THEN ASKED FOR THE PURPLE RADIAL RELOAD TO PERFORM THE DISTAL RESECTION OF THE TISSUE. HE INSERTED THE RELOAD, CYCLED IT ON THE IDRIVE AND PLACED IT AROUND THE RECTAL TISSUE FOR TRANSECTION. THE TISSUE WAS BUNCHED INTO THE JAW SO THE RELOAD AND THEN DR. TRAN ATTEMPTED TO CLOSE IT. UNFORTUNATELY, THE FIRST SEVERAL ATTEMPTS TO CLOSE THE JAWS WITH THE IDRIVE HANDLE DID NOT WORK. UPON MANIPULATING THE TISSUE AND REDUCING THE BUNCHING, THE SURGEON WAS FINALLY ABLE TO CLOSE THE JAWS AND ACHIEVE A GREEN LIGHT STATUS FOR FIRING THE STAPLER. HE INITIATED THE FIRING SEQUENCE AND PRESSED THE BLUE BUTTON TO FIRE. THE STAPLER FIRED AND THEN STOPPED IMMEDIATELY. HE PAUSED AND LOOKED FOR DIRECTION. HE THEN PUSHED THE BLUE BUTTON AGAIN AND THE STAPLE LOAD FIRED SOME MORE BUT AGAIN STOPPED IMMEDIATELY. HE THEN CONTINUED THIS PROCESS WITH ACTIVE BUTTON PUSHING AND THE RELOAD WOULD NO LONGER PUSH THROUGH THE TISSUE. HE THEN CONTINUED THIS PROCESS WITH ACTIVE BUTTON PUSHING AND THE KNIFE BLADE. THE STAPLER OPENED AND HE WAS BALE TO REMOVED THE RELOAD FROM THE TISSUE AND PATIENT. THE STAPLES THAT DID DEPLOY WERE FORMED AND PART OF THE TISSUE WAS TRANSECTED. THE SURGEON THEN ASKED FOR A BLACK RADIAL RELOAD TO COMPLETE THE THICK TISSUE RECTAL TRANSECTION. HE INSERTED THE BLACK RADIAL RELOAD, CYCLED IT ON THE IDRIVE AND THEN PROCEEDED TO PLACE THE JAWS AROUND THE TISSUE AGAIN. HE THEN ATTEMPTED TO CLOSE THE STAPLE LOAD, BUT AGAIN WAS NOT ABLE TO CLOSE IT UNTIL MULTIPLE ATTEMPTS WERE PERFORMED. UPON CLOSING A FOURTH TIME, HE ACHIEVED A GREEN STATUS LIGHT AND HE STARTED THE FIRING SEQUENCE AND FIRED THE RELOAD. THE STAPLER STARTED FIRING BUT JUST LIKE THE PURPLE LOAD BEFORE, IT ONLY FIRED A FEW STAPLES. OUT OF FRUSTRATION THE SURGEON CONTINUED TO PUSH THE BLUE FIRING BUTTON MULTIPLE TIMES AND THEN HAD TO OPEN THE STAPLER WITH THE FREY BUTTON TO REMOVED THE RELOAD FROM THE TISSUE AND PATIENT. AT THIS TIME HE PERFORMED A MINI-LAPAROTOMY AND INSERTED THE ALEXIS WOUND RETRACTOR AND COMPLETED THE SURGICAL TRANSECTIONS WITH MULTIPLE LOADS. SOME MESENTERIC BLEEDING HAD TO BE CONTROLLED DURING THE PROCEDURE AS A RESULT REMOVING THE BLACK RADIAL RELOAD. HOWEVER, THE SURGEON WAS ABLE TO CONTROL AND CORRECT THE BLEEDING AND COMPLETE THE SURGERY. SURGERY TIME WAS DELAYED BY MORE THAN 30 MINUTES; HOWEVER, THE DELAY DID NOT AFFECT THE PATIENT. NO REINFORCEMENT MATERIAL WAS USED. DISPOSED OF BY CLEANING STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258066 ENDO GIA MEDIUM/THICK RADIAL RELOAD DISPOSABLE SURGICA STAPLER GDW COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES N3M0411UX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOT# N3M0411UX, SN (B)(4).| IDRVULTRA1, IDRIVE ULTRA POWERED HANDLE 1,| SN: (B)(4)| EGIAADAPT, ENDO GIA ADAPTER STANDARD,