Intuitive Surgical, Inc.: EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

Is my product affected?

EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.

• UPC 00886874114810

Check against the official notice below — it lists the full affected range.

What happened

Intuitive Surgical, Inc. is recalling EndoWrist Suction Irrigator single-use surgical instruments (Part Number 480299-04) used in endoscopic surgery. The company identified a potential hazard where silicone particles could be generated inside the device and introduced into patients during irrigation. The recall affects 3,108 units distributed worldwide, including the United States, Australia, Italy, Switzerland, and the United Kingdom. The affected devices are from Lot T10180226 and onward.

The source document does not specify a remedy or recommended action for consumers who may have affected devices.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.

Details from the source

Reason for recall: The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation. Distribution: Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom. Quantity: 3108 units (518 boxes of 6 units) Lot/code info: Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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