It was reported to aesculap inc.That two prestige atra grasper dbl-act 5mm (part # 8360-10) were used during a laparoscopic procedure on (b)(6) 2024.According to the complainant, during the procedure, the tip of the device broke off in the patient (ref.Mdr id (b)(4)).A second prestige atra grasper dbl-act 5mm (part # 8360-10) was then used to retrieve the fragments, but the issue recurred.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of this event.However, a five (5) minute surgical delay was reported.The adverse event is filed under aic reference xc (b)(4); cc (b)(4).Reference associated medwatch report 2916714-2024-00075.
|