ETHI16LINK0335 TVT Obturator Key Steps r6 · Key Steps GYNECARE TVT™ Obturator System Tension-free Support for Incontinence The goal is to keep the point of the needle as close

Key Steps

GYNECARE TVT™ Obturator SystemTension-free Support for Incontinence

The goal is to keep the point of the needle as close to the bone as possible using the “Pop, Stop, Drop, Rotate, and Hug the Bone” Key Steps

STEP 1: Position Patient, Mark Exit Points, and makeVaginal Incision

Place patient in dorsal lithotomy with hips hyperflexed to patient’s comfort with the coccyx flush to the edge of the table. Insert a urethral catheter into the bladder and empty the bladder.Note: This positioning ensures proper clearance to allow the handle to drop.

Locate the reference exit points first by tracing a horizontal line at the level of the urethral meatus, and a second line parallel and 2 cm above the first line.

Mark the reference skin exit points on this second line, 2 cm lateral to the folds of the thigh. Do not make incisions at this point.

Using Allis clamps for traction, make a 1 cm midline vaginal incision starting at 1 cm proximal to the urethral meatus.

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STEP 3: Insert the Safety Winged Guide and Helical Passer

Pop and Stop

Insert the Safety Winged Guide into the dissected track and just through the obturator membrane.

Insert the Helical Passer inward along the Winged Guide until you just Pop through the obturator membrane with the Helical Passer. Immediately Stop insertion of the Helical Passer once tactile feel confirms the membrane has been penetrated.

Once in this position, remove the Safety Winged Guide.

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STEP 4: Drop the handle towards Midline

Take care not to advance the needle tip.

Reposition the handle of the Helical Passer by Dropping it towards the midline until the handle is nearly vertical to the floor.

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STEP 2: Dissect

Initiate using sharp dissection.

With the scissors oriented on the horizontal plane, dissect from the vaginal incision using a “push-spread” technique to the inferior pubic ramus.

Stop dissection after the obturator membrane has been perforated.

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S:8”S

:10

.5”

T:8.5”T:1

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B:8.75”B

:11

.25

”

ETHI16LINK0335_TVT_Obturator_Key_Steps_r6.pdf 1 8/11/16 11:56 AM

STEP 5: Rotate the Helical Passer

Rotate the Helical Passer and Hug the Bone (ischo-pubic ramus), until the skin is tented.Note: Hugging the ischo-pubic ramus will aid in reproducible passage through the obturator foramen.

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Rotate and hug the bone STEP 6: Pass through Skin

Stabilize the skin.Note: The point of the Helical Passer may exit medially to the previously marked reference exit points. Under no circumstances should the Helical Passer exit laterally to the previously marked reference skin exit points.

Make skin incision at the point where the tip of the helical passer tents the skin.

Fully rotate the helical passer until the tip of the plastic tube appears at the skin.

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STEP 7: Removal of the Helical Passer

Grasp the extreme point of the exposed tip with a clamp.

Stabilize the tube near the urethra and remove the Helical Passer with a reverse rotation of the handle.

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STEP 9: Repeat Steps 2–8 on Patient’s Other Side

Repeat the technique on the patient’s other side.

Ensure that the mesh lies flat under the urethra.

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STEP 10: Remove Sheath, Adjust Tension, Close

Place a suitable blunt instrument (eg, scissors or forceps) between the urethra and the mesh or other suitable means to avoid positioning the mesh with tension.

Sequentially remove each plastic sheath carefully.

Make final mesh adjustment.

Cut the ends of the tape at skin level.

Close vaginal and skin incisions.

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STEP 8: Pull Plastic Tube

Pull the plastic tube completely through the skin until the tape appears.•

© 2016 Ethicon US, LLC. All rights reserved. 013172-160708

This information is intended as an overview only. Please refer to the INSTRUCTIONS FOR USE included with this device for indications, contraindications, warnings, precautions and other important information about the GYNECARE TVT™ Obturator System.

S:8”S

:10

.5”

T:8.5”T:1

1”

B:8.75”B

:11

.25

”

ETHI16LINK0335_TVT_Obturator_Key_Steps_r6.pdf 2 8/11/16 11:56 AM

Deviation Report

Comparison type: Text

Source(s): ETHI16LINK0335_TVT_Obturator_Key_Steps_r5.pdf (2 pages)

Target: ETHI16LINK0335_TVT_Obturator_Key_Steps_r6.pdf (2 pages)

Report created: 2016-08-11 12:00:32 (yyyy-MM-dd HH:mm:ss)

Performed by: jhendric at station 10.112.25.13

Job/Reference number: ETHI16LINK0335

Deviations: 14

Real deviations: 0

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Selected Source areas: Document: ETHI16LINK0335_TVT_Obturator_Key_Steps_r5.pdf (2 pages)

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Selected Target areas: Document: ETHI16LINK0335_TVT_Obturator_Key_Steps_r6.pdf (2 pages)



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Insert a urethral catheter into the bladder and emptythe bladder.

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remove the second bullet as it should not be there

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Obturator SystemTension-free Support for IncontinenceKey Steps

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the table.Note: This

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the table. Insert a urethralcatheter into the bladder and empty the bladder.Note: This

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todrop.• Locate the

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first line.↓• Mark the reference sking exit points

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first line.• Mark the reference skin exit points

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this point.↓• Using Allis


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• Place blunt instrument

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the urethra↓• and the

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with tension.Note: Use a suitable instrument to avoid positioning the meshwithtension.• Sequentially

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with tension.• Sequentially

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mesh adjustment.↑• Cut the


mesh adjustment.• Cut the

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reserved. 013172-160701

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Documents

ETHI16LINK0335 TVT Obturator Key Steps r6 · Key Steps GYNECARE TVT™ Obturator System Tension-free Support for Incontinence The goal is to keep the point of the needle as close