Intuitive Surgical Recalls EndoWrist Stapler 45 Instruments
Intuitive Surgical is recalling 1,034 EndoWrist Stapler 45 instruments because they may not be removable from tissue.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a surgical instrument that cannot be removed from tissue, which constitutes a significant injury risk during surgery.
Plain-English summary
Intuitive Surgical, Inc. is recalling 1,034 EndoWrist Stapler 45 instruments (Model Number IS3000) for the da Vinci Si System. The recall covers all lots of the instrument, specifically part numbers PN 410298-06, -07, -08, and -09. The devices were distributed nationwide in the United States.
The recall was issued due to reports that the stapler cannot be removed from tissue. This issue poses a risk to patients during surgical procedures.
Healthcare facilities and users of the EndoWrist Stapler 45 should discontinue use of the affected instruments immediately. Intuitive Surgical has issued an urgent product notice to all users regarding this defect.
The recalled product
- Product
- EndoWrist Stapler 45 instrument for the da Vinci Si System Model Number: IS3000 Product Usage: For use with da Vinci Si System. The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic…
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 1,034
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- EndoWrist Stapler 45 instrument
- Model Number: IS3000 Part Number: PN 410298-06
- -07
- -08
- -09 All Lots.
Distribution
Distributed nationwide across the United States.
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