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Recall Observatory FDA recall evidence

Device product

Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm

Z-0406-2024

October 06, 2023

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 93301
Status
Ongoing
Classification
Class II
Quantity
317 units
Official record key
device-enforcement:Z-0406-2024

Official wording

Reason: There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.

Code information: UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503, T10220518, T10220629, T10220715, T10220721, T10220811, T10220819, T10220901, T10220909, T10220920, T10220923, T10220928, T10221101, T10221109, T10230207, T11221109

Distribution pattern: US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico OUS: South Korea

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.