Da Vinci Needle Driver Recalled for Risk of Dislodgement During Surgery
Intuitive Surgical is recalling 317 units of a Da Vinci Single-Site Wristed Needle Driver due to potential dislodgement or breakage that could result in uncontrollable movement.
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: This is an FDA Class II recall of a surgical instrument where the needle drive may become dislodged or broken, potentially causing uncontrollable movement. No illnesses or injuries have been reported in the source text. Per the rubric, when no injuries are reported and the hazard is theoretical, the score is at most 3 (High).
Plain-English summary
Intuitive Surgical, Inc. is recalling 317 units of the Da Vinci Single-Site Wristed Needle Driver (REF: 478115, 5 mm).
The needle drive may become dislodged and/or broken, which could result in uncontrollable movement.
The recalled units have been distributed to healthcare facilities in Illinois, Florida, Idaho, South Carolina, Michigan, Texas, Tennessee, New York, Oregon, Colorado, California, Mississippi, New Jersey, and Puerto Rico, as well as to South Korea. Affected units can be identified by the following serial numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109.
Users should immediately identify units with these serial numbers and cease their use. Contact Intuitive Surgical, Inc. for instructions on replacement or further guidance.
The recalled product
- Product
- Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 317
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 (19)
- UDI:00886874113752/ Serial Numbers: T10220412
- T10220420
- T10220426
- T10220503
- T10220518
- T10220629
- T10220715
- T10220721
- T10220811
- T10220819
- T10220901
- T10220909
- T10220920
- T10220923
- T10220928
- T10221101
- T10221109
- T10230207
- T11221109
Distribution
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