Device product
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
Z-0249-2020
Product summary
- Event
- Event 81073
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3108 units (518 boxes of 6 units)
- Official record key
device-enforcement:Z-0249-2020
Official wording
Reason: 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.
Code information: Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)
Distribution pattern: Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.
Derived failure modes
-
Unknown
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.