Intuitive Surgical Recalls da Vinci EndoWrist Scissors Due to Cracking Risk
Intuitive Surgical is recalling 42,274 da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors because cracks may form in the extension tube, potentially causing fragments to fall into patients.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of foreign body fragments entering the patient, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Intuitive Surgical, Inc. is recalling 42,274 units of the da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors (Model No. 470179-14). The recall covers instruments distributed worldwide, including nationwide distribution across all 50 U.S. states and the District of Columbia.
The recall was initiated because the instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, which may cause fragments of the extension tube to fall, including potentially into the patient.
The affected instruments are intended for endoscopic manipulation of tissue during various surgical procedures, including urologic, general laparoscopic, gynecologic, and thoracoscopic procedures. The source text does not report any specific illnesses or injuries associated with this defect.
The recalled product
- Product
- da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt…
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 42,274
Distribution
Part of a larger recall action
This product is one of 2 recalled by Intuitive Surgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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