da Vinci tenaculum forceps recalled over frayed or broken pitch cables
Intuitive Surgical is recalling da Vinci S and Si Tenaculum Forceps Instruments following increased complaints regarding frayed or broken pitch cables on reusable surgical 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, Si Tenaculum Forceps Instrument, model 420207. The EndoWrist reusable instruments are intended for endoscopic manipulation of tissue, including grasping, cutting, dissection, ligation, electrocautery and suturing. About 2,095 instruments were distributed across 24 US states and more than forty other countries. The FDA has classified this recall as Class II.
The recall follows an increase in complaints regarding frayed or broken pitch cables on reusable surgical instruments.
Affected product carries GTIN 00886874111659, across the material 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 Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp end
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Robotic surgery
- Affected units
- 2,095
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.
See all 2 products in this recall →Related recalls
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