Reported Mar 9, 2022 · Ongoing
da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Intuitive Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intuitive Surgical, Inc. · 1266 Kifer Rd Bldg 101 · Sunnyvale, CA · 94086-5304
Is this the product you have?
- da Vinci Xi and X 12-8 mm Conductive Cannula Reducer
- REF470381-11
- Lot codes and dates
- UDI
71 of 71 codes
00886874112588L10210114L10210115L10210122L10210125L10210128L10210204L10210205L10210211L10210212L10210215L10210216L10210217L10210218L10210219L10210225L10210226L10210301L10210304L10210305L10210308L10210309L10210316L10210317L10210318L10210321L10210322L10210513L10210514L10210520L10210521L10210527L10210528L10210529L10210715L10210716L10210717L10210718L10210719L10210720L10210722L10210723L10210731L10210801L10210803L10210805L10210806L10210807L10210808L10210809L10210812L10210813L10210819L10210924L10210925L10210926L10210930L11210111L11210316M10210330
- UDI
- Amount recalled
- 149,646 reducers
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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