da Vinci monopolar curved scissors recalled over frayed grip cables
Intuitive Surgical is recalling da Vinci S and Si Monopolar Curved Scissors Instruments following increased complaints of broken or frayed grip cables in reusable instruments.
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported: broken or frayed drive cables in a robotic surgical instrument are a hazard during a procedure, and no injuries are stated.
Plain-English summary
Intuitive Surgical, Inc. is recalling the da Vinci S and Si Monopolar Curved Scissors Instrument, model 420179. The EndoWrist reusable instruments are intended for endoscopic manipulation of tissue, including grasping, cutting, dissection, ligation, electrocautery and suturing, and use mechanical tungsten cables and pulleys to transmit motion from the input discs. About 86,904 units were distributed across 20 US states and more than thirty other countries. The FDA has classified this recall as Class II.
The recall follows increased complaints for broken or frayed grip cables in reusable instruments.
Affected product carries GTIN 00886874111505, across the batch and system numbers listed in the FDA enforcement record.
Facilities can identify affected instruments by the model number and GTIN above, and may contact Intuitive Surgical, Inc. for further information.
The recalled product
- Product
- Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Robotic surgery
- Affected units
- 86,904
Distribution
Part of a larger recall action
This product is one of 4 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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