# K140553: Endowrist Stapler 45 and Stapler 45 Reloads

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Jul 25, 2014 after 143 days
- Product code: NAY (System, Surgical, Computer Controlled Instrument)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 23 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
18 later devices descend from it; 5 cite it directly.
3 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Intuitive Surgical Endo Wrist Stapler 45 System and Stapler 45 Reloads (for use with da Vinci IS3000 System): named in the summary without a submission number
- (no number) ENDOPATH ETS Reload (White): named in the summary without a submission number

## Most influential descendants
- K152421: IS4000 Stapler 30 Instrument and Stapler 30 Reloads (2016), 14 descendants of its own
- K170508: EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads (2017), 12 descendants of its own
- K173721: SureForm 60 and SureForm 60 Reloads (2018), 6 descendants of its own
- K183224: SureForm 45, SureForm 45 Reloads (2019), 5 descendants of its own
- K190999: SureForm 45 Curved Tip, SureForm 45 Gray Reload (2019), 4 descendants of its own

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0702-2022: Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip
- Apr 23, 2018 · Class II · Z-2380-2018: Intuitive Surgical, Inc. (ISI) has recently become aware of an issue with the da Vinci Xi Stapler 45 Blue and Green Reloads that may be missing a component of the knife mechanism. Without this compone
- Sep 19, 2017 · Class II · Z-0404-2018: Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit
- Mar 15, 2017 · Class II · Z-1723-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1721-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1718-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1722-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1724-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1728-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1719-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1720-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1714-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1715-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1717-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1716-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1726-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1727-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1725-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Mar 15, 2017 · Class II · Z-1729-2017: Intuitive Surgical has become aware and further investigation has determined that misinterpretation of instructions provided on the IS4000 Stapler Release Kit instruction card may result damage of the
- Jul 14, 2016 · Class II · Z-2348-2016: An increase in the number of da Vinci EndoWrist Stapler complaints where the customer experienced a Stapler Firing Failed message as well as review of da Vinci Xi Surgical System logs found an increas
- Jul 14, 2016 · Class II · Z-2676-2016: Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
- Jul 14, 2016 · Class II · Z-2675-2016: Field failures were reported related to the da Vinci Xi Surgical System EndoWrist Stapler 45 and 30 instruments having an interruption in shaft rotation and / or instrument jaws not opening.
- May 9, 2016 · Class II · Z-1837-2016: Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula lumen when insufflation is connected during

## Indications for use
The Intuitive Surgical Endo Wrist® Stapler 45, Stapler 45 Reloads and other Stapler Accessories are intended to be used with the da Vinci® Surgical System (Model 1S4000) for resection, transection and/or creation of anastomoses in General, Thoracic, Gynecologic and Urologic surgery. The device can be used with staple line or tissue buttressing material (natural or synthetic).

Source page: https://510kreport.com/device/K140553
Methodology: https://510kreport.com/methodology