Recall Z-0702-2022— Intuitive Surgical, Inc.

Name: FDA recall Z-0702-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-23

Class II · Ongoing

Class II FDA medical device recall by Intuitive Surgical, Inc., initiated 2021-12-23. It names 2 FDA 510(k) clearances: K162411, K140553. Product: da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11. Reason: Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain..

Recalling firm: Intuitive Surgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-12-23
Firm location: Sunnyvale, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K162411 — da Vinci Xi 12 8 mm ReducerIntuitive Surgical, Inc.·cleared 2016-09-21
K140553 — ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADSIntuitive Surgical, Inc.·cleared 2014-07-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11

Reason for recall

Conductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal tip. If the procedure proceeds without the metal tip, there is potential for energy leakage, which could cause tissue damage. If the metal tip remains in the patient, adhesions may form, which may lead to bowel obstruction and chronic abdominal pain.

Data sourced from openFDA. This site is unofficial and independent of the FDA.