EndoWrist Stapler 45 and Stapler 30 instruments used on recall: Software Issue
EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical…
Why was EndoWrist Stapler 45 and Stapler 30 instruments used on recalled?
Potential for unexpected motion of the Xi Stapler jaws on the da Vinci Xi System with p5 software relating to a combination of the p5 software and the surgeon quickly transitioning from the clamp to the fire pedal during use.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
da Vinci systems with serial numbers: SK0036 SK0292 SK0650 SK0039 SK0293 SK0652 SK0057 SK0294 SK0653 SK0101 SK0326 SK0654 SK0106 SK0358 SK0665 SK0119 SK0360 SK0701 SK0143 SK0382 SK0702 SK0144 SK0408 SK0710 SK0146 SK0438 SK0722 SK0171 SK0456 SK0728 SK0173 SK0484 SK0181 SK0492 SK0216 SK0496 SK0230 SK0516 SK0233 SK0548 SK0237 SK0552 SK0238 SK0610 SK0263 SK0612 SK0286 SK0631 SK0291 SK0649.
- Product
- EndoWrist Stapler 45 and Stapler 30 instruments used on the da Vinci Xi systems (IS4000) with p5 software. General Surgery: The Intuitive Surgical…
- Recalling firm
- Intuitive Surgical, Inc.
- Quantity
- 43
- Distribution
- US Nationwide Distribution in the states of: WI, FL, OH, TX, CA, AZ, IL, MD, MN, NY, OK, HI, MO, IA, KS, PA, and AL.
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)