EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
Reported: November 6, 2019 Initiated: June 4, 2018 #Z-0249-2020
Product Description
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.
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.
Details
- Recalling Firm
- Intuitive Surgical, Inc.
- Units Affected
- 3108 units (518 boxes of 6 units)
- Distribution
- Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.
- Location
- Sunnyvale, CA
Frequently Asked Questions
What product was recalled? ▼
EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. An accessory to the EndoWrist Surgical System, used in endoscopic surgery.. Recalled by Intuitive Surgical, Inc.. Units affected: 3108 units (518 boxes of 6 units).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 6, 2019. Severity: Moderate. Recall number: Z-0249-2020.
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