daVinci X EndoWrist(R) Stapler 45, REF 470298 Product Usage: The Intuitive Surgical EndoWrist Stapler 45, Stapler 45 Reloads, and other Stapler Accessories (including the bladeless obturators) are intended to be used with the da Vinci Surgical System (Model IS4000) for resection, transection, and/or
Check against the official notice below — it lists the full affected range.
Intuitive Surgical, Inc. is recalling 60 units of the daVinci X EndoWrist Stapler 45 distributed nationwide in the United States. The recall affects specific instruments with serial numbers S10170630, S11170705, S10170707, and S10170731. These instruments may have a manufacturing defect where the Stapler Release Kit (SRK) Wrench interface feature is manufactured to an incorrect dimension, which could prevent the SRK Wrench from being able to manually unclamp the instrument.
The source document does not specify a remedy or corrective action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument.
Reason for recall: Specific da Vinci Xi EndoWrist Stapler 45 instruments are potentially impacted by a variation in the manufacturing process. In affected instruments, there is a possibility that the Stapler Release Kit (SRK) Wrench interface feature accessed through release hole 2 is manufactured to an incorrect dimension, which may prevent the SRK Wrench from being able to manually unclamp the instrument. Distribution: US Nationwide Distribution Quantity: 60 units Lot/code info: UDI 00886874112427: Serial Numbers: S10170630, S11170705, S10170707, S10170731
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.