da Vinci Xi and X 12-8 mm Conductive Cannula Reducer, REF: 470381-11
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. has recalled approximately 149,646 da Vinci Xi and X 12-8 mm Conductive Cannula Reducers due to a defect in which the metal tip may become dislodged from the plastic shaft. The affected devices were distributed worldwide and throughout numerous U.S. states and are identified by specific lot codes beginning with L10210114 through M10210430, with UDI 00886874112588.
If the metal tip becomes dislodged during surgery without being noticed, patients may require additional surgery to remove it. Alternatively, if the procedure continues without the metal tip, energy leakage may occur causing tissue damage. If the metal tip remains inside the patient, adhesions may develop that could lead to bowel obstruction and chronic abdominal pain. The recall record does not specify what actions affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: Worldwide distribution - US Nationwide distribution in the states of California, Wisconsin, Virginia, Ohio, Texas, New York, Nevada, Connecticut, New Jersey, Massachusetts, Georgia, Florida, Indiana, North Carolina, Missouri, Pennsylvania, Michigan, Oregon, Kentucky, Hawaii, Tennessee, Alabama, Nebraska, Maryland, Oklahoma, Colorado, Arkansas, Arizona, Kansas, Illinois, South Carolina, Minnesota, Quantity: 149,646 reducers Lot/code info: UDI: 00886874112588 L10210114 L10210115 L10210122 L10210125 L10210128 L10210204 L10210205 L10210211 L10210212 L10210215 L10210216 L10210217 L10210218 L10210219 L10210225 L10210226 L10210301 L10210304 L10210305 L10210308 L10210309 L10210316 L10210317 L10210318 L10210321 L10210322 L10210513 L10210514 L10210520 L10210521 L10210527 L10210528 L10210529 L10210715 L10210716 L10210717 L10210718 L10210719 L10210720 L10210722 L10210723 L10210731 L10210801 L10210803 L10210805 L10210806 L10210807 L10210808 L10210809 L10210812 L10210813 L10210819 L10210924 L10210925 L10210926 L10210930 L11210111 L11210316 M10210330 M10210331 M10210405 M10210408 M10210409 M10210412 M10210415 M10210416 M10210422 M10210423 M10210429 M10210430
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.