OPENING THE DOOR TO EASY PORT-SITE CLOSURES....Consistent Closure1 The ™VersaOne fascial closure system is designed to facilitate closure of the fascia at 5 mm on either side 4–7of

OPENING THE DOOR TO EASY PORT-SITE CLOSURES.1

Product information guide

VersaOne™ Fascial Closure System

TABLE OF CONTENTS

03 Fulfillinganeedinlaparoscopicsurgery

04 IntroducingtheVersaOne™ fascialclosuresystem

05 Featuresandbenefits

06 Applicationguide

09 Ordering information

SUPPORTING SURGEONS WHEN IT’S CLOSING TIME.

We’reexcitedtointroducethelatestadvancementinourVersaOne™ trocar platformfamily:the VersaOne™ fascial closure system.

LikeallofourVersaOne™trocars,itprovidesaccesstostandardlaparoscopicinstruments.Butitalsodeliversconsistentclosure1oftheportsite.

Thisuniquedeviceispartofourcommitmenttohelpingyouimproveproceduralefficiency—fromtheinitialmomentsofsurgerytothefinalsuture.1,†

†Comparedtothecompetitiveclosuredevice,suturepasser,andsutureonly.

Addressing a Procedural Need

TRADITIONAL SUTURING

Difficultandimprecise,especiallyinobese patientsandinalllaterallyplacedtrocarsite2

SUTURE PASSER

Inexactsutureplacement3

CLOSURE DEVICE

Reinsertionaftertrocar removal

ACCESS AND CLOSURE MADE EASY1

TheVersaOne™fascialclosuresystemisamultifunctionaltoolthatservesasatrocarandafascialclosuredevice.Itdelivers:

▪Consistentport-siteclosure1

▪Addedproceduralefficiency1,† ▪Easeofuse1

WedevelopedtheVersaOne™fascialclosuresystembecausethere’saneedforaconsistentsolutionforclosuresattheportsite.1

Traditionalfascialclosuretechniques:

†Comparedtothecompetitiveclosuredevice,suturepasser,andsutureonly.

Consistent Closure1 TheVersaOne™fascialclosuresystemisdesignedtofacilitateclosureofthefasciaat5mmoneithersideofthewound.4–7

Efficient Access and Closure1

Theall-in-one1systemcanhelpsavetimebecauseit:

▪ Eliminatestheneedtoremovetrocarbeforeclosure1

▪ Makesreinsufflationunnecessary—pneumoperitoneum canbemaintainedthroughouttheprocedure1

▪ MayhelptoreducethenumberofSKUsrequired

FEATURES AND BENEFITS

Visualindicatorsaidintrocarplacement1

Cannulawindowandguidehelpfacilitateclosureofthefasciaat5mmoneithersideofthe cannula defect4–7

A B

Reusable Suture Passer

Needle tip

Flush port

Stop function

ABC

System Components

A

B

C

E

D

F

Guide

Distal black band

Distal cannula window

Proximal black band

Arrow

Obturator

ABCDEF

ALL-IN-ONE ACCESS AND CLOSURE1

How to use the VersaOne™ fascial closure system

C

STEP 1Removethesealhousingonthecannula byrotatingtheself-adjustingseal counter-clockwisewhiledepressing thespecimenremovalbutton.

Important: Do not insert the guide into the seal housing.

STEP 2Fullyinsertthedisposableguideintothe cannulauntilaclickisheardandtheguide islockedinplace.

STEP 3Ensurethedistalblackbandontheguide isalignedwiththeperitoneumandthe proximalblackbandisbelowtheskin.

Specimen removal button

Seal housing

Proximal black band

Distal black band

STEP 4Graspashorttailofsuturewiththe suturepasser.†

STEP 5A.Insertthesuturepasserdown eitheroneofthetwoguidechannels.Advancethesuturepasser andsuturethroughthetissue andintotheabdominalcavity.

B.Usethesecondarygrasperfromthealternateporttograsp thesuture.Releasethesuturefromthesuturepasserjaw.

STEP 6A. Inserttheempty suturepasserdownthe oppositeguidechannelintotheabdominalcavitytograbthesuture.

B.Pickupthesutureandremoveitthroughtheguide.

C.Removethecannulaandguideassemblyfromdefect andtieoff.

†ThetrocarandguidewillaccommodateKarlStorz™*BERCIfascialclosureinstrument.8,9

ORDERING INFORMATION

Code Description Per Box

ONB12STFCS VersaOne™FascialClosureSystemOpticalTrocar 6unitsperbox

B12STFCS VersaOne™FascialClosureSystemBladedTrocar 6unitsperbox

FCSPASS VersaOne™FascialClosureSystemReusableSuturePasser 1unitperbox

1. Basedoninternalvalidationreport#RE00098009RevA,DoubleTimeVersaOne™ fascialclosuresystemMiamilabVOCreport:13outof16surgeonssurveyedagreed.March28,2017.

2. NadlerRB,McDougallE,BullockAD,LudwigMA,BruntLM.Fascialclosureoflaparoscopicportsites:anewtechnique.Urology.1995;45(6):1046–1048.

3. EidGM,CollinsJ.Applicationofatrocarwoundclosuresystemdesignedforlaparoscopicproceduresinmorbidlyobesepatients.Obes Surg.2005;15(6): 871–873.

4. Basedoninternalreport#RE00003570,VOCsummarydetailingcustomerrequirementsforprojectDoubleTime,ascompiledfromsurveysatSAGES2013:16outof16surgeonsagreed.Nov.5,2014.

5. Basedoninternalreport#RE00079705,Fascialclosuresystembitesizeverification.Nov.5,2014.

6. IsraelssonLA.Abdominalincisionclosure:smallbutimportantbites.Lancet. 2015;386(10000):1216–1218.

7. Basedoninternalreport,VOCsummaryreport,CustomerrequirementsforprojectDoubleTimefromsurveysatSAGES2013:16outof16surgeonssurveyedagreed.May6,2013.

8. Basedoninternalvalidationreport#RE00031915,ProjectDoubleTimeVersaOne™ fascialclosuresystem,surgeonformativeusabilityevaluation.November12,2015.

9. Basedoninternalvalidationreport#2197RevC1,ProjectDoubleTimeVersaOne™ fascialclosuresystem,designinputtraceabilitymatrix.March21,2017.

©2020Medtronic.Allrightsreserved.Medtronic,MedtroniclogoandFurther,TogetheraretrademarksofMedtronic.™*Thirdpartybrandsaretrademarksoftheirrespectiveowners.AllotherbrandsaretrademarksofaMedtroniccompany.02/2020–US170389(5)–[WF#1561527]

Important:Alwaysrefertotheinstructionsforuse(IFU)suppliedwiththeproductforcompleteinstructions,indications,contraindications,warnings,andprecautions.

For more information or to order the VersaOne™ fascial closure device, call 800-772-8772Visit us at medtronic.com/versaone-closure