Agency classClass IIOur severity:High FDA (Devices)·Z-3024-2018·Announced 2018-09-19

Intuitive Surgical Recalls da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors

Intuitive Surgical is recalling 23,064 da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors because cracks in the extension tube may cause plastic 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 constitutes a risk-of-harm product where injury has not yet been reported, aligning with the High severity criteria.

Plain-English summary

Intuitive Surgical, Inc. is recalling 23,064 units of the da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors (Model No. 420179-16). The recall covers instruments distributed worldwide, including across all 50 U.S. states, Washington D.C., and numerous international countries.

The recall was initiated because the Monopolar Curved Scissor (MCS) 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, potentially causing fragments of the extension tube to fall, including into the patient.

The affected instruments are intended for endoscopic manipulation of tissue during various surgical procedures, including urologic, general laparoscopic, gynecologic laparoscopic, transoral otolaryngology, general thoracoscopic, and thoracoscopically assisted cardiotomy procedures. The devices are intended for use by trained physicians in an operating room environment. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.

The recalled product

Product: da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 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.
Category: Medical Device — Surgical Instrument
Hazard: foreign-body
structural-failure
Affected units: 23,064

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 →

Same manufacturer · Intuitive Surgical, Inc.

See all →

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Intuitive 8 mm SureForm 30 Gray Reloads Incomplete Staple Defect
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Same hazard · foreign body