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Recall Observatory FDA recall evidence

Device product

8MM, DUAL BLADE RETRACTOR; Intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.

Z-0443-2015

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-0443-2015

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; 470249-04; 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.