BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE ILS STAPLER

    MDR report key: 3963116 · Received July 29, 2014

    Report

    Report Number
    3005075853-2014-05303
    Event Type
    Injury
    Date Received
    July 29, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 14, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED: HAS THE PATIENT UNDERGONE AND CHEMO/RADIATION THERAPY? NO INFORMATION. COULD YOU PROVIDE PATIENT AGE, GENDER AND RELEVANT MEDICAL HISTORY? NO INFORMATION. HOW MANY REVOLUTIONS WAS THE TURNED PRIOR TO REMOVAL? NO INFORMATION. HOW LONG HAS THE SURGEON BEEN USING THIS DEVICE (CDH29A) FOR THIS PROCEDURE? NO INFORMATION. WHO FIRED THE DEVICE (ATTENDING, P.A, TECH., ETC.)? RESIDENT (ATTENDING LED HIM) COMMENTS: PER THE IFU IN STEP 9 AFTER FULLY FIRING THE DEVICE, ¿OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS.¿ THIS STEP RELIEVES THE COMPRESSION FORCES ON THE TISSUE AND ALLOWS IT TO SLIDE OUT OF THE DEVICE. ADDITIONALLY, STEP 10 READS, ¿TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS TO WITHDRAW.¿ THIS STEP ALSO HELPS TO RELEASE THE TISSUE FROM THE INSTRUMENT. CONCLUSION: BASED ON THE PHOTO AND VIDEO EVIDENCE, THE BELIEF IS THAT THE DEVICE WAS NEITHER OPENED ONE-HALF TO THREE-QUARTER TURNS NOR WAS IT ROTATED TO FREE IT FROM THE TISSUE, PER THE IFU, PRIOR TO ATTEMPTED REMOVAL. IT APPEARS THAT THE TISSUE WAS STILL BEING COMPRESSED IN THE INSTRUMENT DURING THE REMOVAL PROCESS AND WAS POSSIBLY THE CAUSE OF THE COMPLICATION. DEVICE ANALYSIS SHOULD CONFIRM THE DEVICE FIRED AND CUT THE BREAKAWAY WASHER AND TISSUE AS DESIGNED. THE ANALYSIS RESULTS FOUND THAT THE CDH33 DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. IN ADDITION ANOTHER ANVIL WAS RECEIVED WITH THE WASHER CUT. FURTHER ANALYSIS OF THE DEVICE SHOWED THAT THE KNIFE WAS NICKED AND THE WASHERS HAD INDENTATIONS. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. THE DAMAGE THE KNIFE IS CONSISTENT WHEN THE DEVICE IS FIRED OVER AN ALREADY EXISTING STAPLE LINE OR HARD OBJECT. IT SHOULD BE NOTED THAT WHEN REMOVING THE DEVICE; OPEN THE INSTRUMENT BY TURNING THE ADJUSTING KNOB COUNTERCLOCKWISE. FOR EASY REMOVAL, ONLY OPEN THE INSTRUMENT ONE-HALF TO THREE-FOURTHS REVOLUTIONS. TO ASSURE THE ANVIL IS FREE FROM TISSUE, ROTATE THE INSTRUMENT 90° IN BOTH DIRECTIONS. TO WITHDRAW THE OPEN INSTRUMENT, GENTLY APPLY REARWARD TRACTION WHILE SIMULTANEOUSLY ROTATING. PLEASE REFERENCE INSTRUCTIONS FOR USE FOR ADDITIONAL INFORMATION NEEDED. NO INCIDENT RELATED TO THE REPORTED EVENT WAS OBSERVED DURING THE BATCH RECORD REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAP SIGMOIDECTOMY, THE DEVICE WAS NOT ABLE TO BE REMOVED FROM THE PATIENT AFTER ANASTOMOSIS BETWEEN THE COLON AND THE RECTUM. WHEN THE DEVICE WAS PULLED FORCIBLY, THE ANTERIOR WALL OF THE RECTUM ON THE ANUS SIDE WAS TORN. THE PROCEDURE WAS CONVERTED TO OPEN TO REPAIR THE SITE. THE DAMAGED SITE WAS RESECTED AND ANASTOMOSED. THE TARGET TISSUE WAS REGULAR AND TAKEN INTO THE DEVICE PROPERLY. THE ANVIL SIDE OF TARGET TISSUE WAS SUTURED WITH A PURSE-STRING DEVICE AND THEN ADDITIONAL SUTURE WAS PERFORMED, AND THE HOUSING SIDE WAS CUT WITH A POWERED LINEAR CUTTER DEVICE LOADING A GOLD CARTRIDGE. THE ANVIL WAS SET PROPERLY WITH A CLICK SOUND. THE INDICATOR WAS WITHIN THE GREEN ZONE PRIOR TO FIRING (THE DOCTOR COMMENTED THAT THE INDICATOR WAS 2/3). THE CLOSING FORCE WAS REGULAR. THE WASHER WAS CUT AND THE STAPLES WERE FORMED PROPERLY. THE FIRING HANDLE WAS FULLY GRASPED. THE DONUTS WERE CREATED PROPERLY, BUT IT WAS UNCLEAR IF THE INNER TISSUE WAS CUT PROPERLY BECAUSE THE SITE WAS INVISIBLE. WE ARE PRESENTLY CHECKING DETAILED INFORMATION INCLUDING THE PATIENT¿S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440918 PROXIMATE ILS STAPLER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA K4D43G

    Patients

    Seq Age Sex Outcome Treatment
    1