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Recall Observatory FDA recall evidence

Device product

8MM PERMANENT CAUTERY SPATULA,; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Z-0437-2015

November 03, 2014

Class II

Product summary

Firm
Intuitive Surgical, Inc.
Event
Event 69638
Status
Terminated
Classification
Class II
Quantity
509 total units - all affected devices
Official record key
device-enforcement:Z-0437-2015

Official wording

Reason: Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.

Code information: Part number 470184-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.

Distribution pattern: US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.