da Vinci SP Instruments and Accessories
Appendix D: Intended Use Statements
75
DR
AFT/PRE-RELEASE/C
ONFIDENTIAL
12/5/19
D
Appendix D: Intended Use Statements
The following intended use statements apply to the da Vinci SP instruments and accessories.
For information on specific indications for use and representative uses of the da Vinci SP
Surgical System, refer to the appropriate da Vinci SP supplement.
Product
Part Number
Intended Use
EndoWrist SP Camera, 0
°
430060
The EndoWrist SP Camera, 0
°
is intended to provide stereoscopic
visualization of tissue and instruments when performing procedures
with the da Vinci SP System.
Needle Driver
430006
The Needle Driver is intended to be used with the da Vinci SP System
to drive needles and tie suture.
Round Tooth Retractor
430002
The Round Tooth Retractor is intended to be used with the
da Vinci SP System for retracting, grasping and manipulating tissues.
Cadiere Forceps
430009
The Cadiere Forceps is intended to be used with the
da Vinci SP System for dissecting, grasping, manipulating, and
retracting tissues.
Medium-Large Clip
Applier
430005
The Medium-Large Clip Applier is intended to be used with the
da Vinci SP System for the application of Weck® Hem-o-lok®
Medium-Large Polymer Ligating Clips for ligation of vessels and
tissue bundles ranging in size from 3 - 10 mm in diameter.
Monopolar Curved
Scissors and MCS Tip
430004
430035
The Monopolar Curved Scissors with MCS Tip is intended to be used
with the da Vinci SP System for manipulating, cutting, and dissecting
tissue, coagulating and transecting tissue using monopolar
electrosurgical energy, and cutting suture. The MCS Tip is also
intended to provide electrical insulation over a section of the
Monopolar Curved Scissors instrument so that RF energy is only
available at the scissor blades.
Monopolar Cautery
Instrument and
Monopolar Cautery Tips
430007
400156
400160
The Monopolar Cautery Instrument with the 5 mm Cautery Hook Tip
or 5 mm Cautery Spatula Tip is intended to be used with the
da Vinci SP System for manipulating and dissecting tissue and
coagulating and transecting tissue using monopolar electrosurgical
energy.
Bipolar Instruments
430010
430011
The Maryland Bipolar Forceps and Fenestrated Bipolar Forceps are
intended to be used with the da Vinci SP System for dissecting,
grasping, manipulating, retracting, and coagulating tissues and
vessels.
Bipolar Cautery Cord
470384
The Bipolar Cautery Cord is intended for connecting bipolar
electrosurgical instruments to an electrosurgical generator to
provide transmission of high frequency current from the
electrosurgical generator to the surgical instrument.
EnergyShield Monopolar
Cautery Cord
430068
The EnergyShield Monopolar Cautery Cord is intended to conduct
high frequency current from the electrosurgical generator and
EnergyShield Monitor to a da Vinci shielded monopolar instrument.
SP Cannula, SP Obturator,
and EntryGuide Kit
430036
430016
430022
The SP Cannula, SP Obturator, and EntryGuide Kit are intended to
establish a port of entry for EndoWrist SP instruments, EndoWrist SP
cameras, and compatible accessories.
