The Recall Desk
HighFDA (Devices)·Z-3025-2018·Announced 2018-09-19

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.

What this means for you

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 and
Affected units
42,274

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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.

See all 2 products in this recall →