Intuitive Surgical Recalls Monopolar Curved Scissors Due to Thermal Injury Risk
Intuitive Surgical is recalling approximately 132,441 EndoWrist Monopolar Curved Scissors instruments worldwide. The recall addresses potential cracks that may cause electrosurgical energy leaks and thermal injury to 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 risk of thermal injury to tissue, which aligns with the rubric criteria for a Severe rating involving significant injury reports or high-risk medical device defects.
Plain-English summary
Intuitive Surgical, Inc. is recalling approximately 132,441 units of the 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears), specifically versions 09 and 10. The affected model numbers are 420179-09, 420179-10, 400179-09, and 400179-10. These instruments are multiple-use endoscopic tools used in conjunction with the Intuitive Surgical Endoscopic Instrument Control System.
The recall was initiated because the company identified a potential for some units to develop very small cracks near the distal end. These cracks may create a pathway for electrosurgical energy to leak to tissue, which could potentially cause thermal injury. The agency has classified this recall as Class II.
The affected instruments were distributed worldwide, including nationwide in the United States and in numerous foreign countries such as Canada, the United Kingdom, Germany, and Japan. No specific dates or lot numbers are provided in the source text.
The recalled product
- Product
- 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distributed by: Intuitive Surgical Sunny vale, CA The EndoWrist Monopolar Curved Scissors Instrument is a multiple-use endoscopic instrument utilizing a single use, tip cover accessory, to be used in…
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 132,441
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 (1)
- Model Numbers 420179-09 and -10 and 400179-09 and -10.
Distribution
Distributed nationwide across the United States.
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