da Vinci permanent cautery hook recalled over frayed pitch cables
Intuitive Surgical is recalling da Vinci S and Si Permanent Cautery Hook 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 Permanent Cautery Hook Instrument, model 420183. The EndoWrist reusable instruments are intended for endoscopic manipulation of tissue, including grasping, cutting, dissection, ligation, electrocautery and suturing. About 6,152 instruments were distributed across 24 US states and more than thirty 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 00886874111536, 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 Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and
- Manufacturer
- Intuitive Surgical, Inc.
- Category
- Medical Device — Robotic surgery
- Affected units
- 6,152
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)
- Lot Code: 420183
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.
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