Intuitive Surgical Recalls EndoWrist Stapler Manuals for pH Specification Change
Intuitive Surgical is recalling EndoWrist Stapler 45 User Manual Addenda and Wall Charts to correct the pH range specification for enzymatic cleaners.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a labeling error regarding cleaning specifications, which is a moderate risk if not corrected, but no injuries or illnesses are reported in the source text.
Plain-English summary
Intuitive Surgical, Inc. is recalling the EndoWrist Stapler System User Manual Addendum and Wall Chart. The recall involves two units of the documentation, specifically model numbers 410298-05 and 410298-06. These documents are intended to be used with the EndoWrist Stapler 45 System and Reloads, which are utilized with the da Vinci Si Surgical System for general, gynecologic, and urologic surgery.
The reason for the recall is a modification to the pH range specification for the enzymatic cleaner used in the cleaning process. The specification was changed from "pH-neutral" to "pH-neutral to mild alkaline (mild alkaline is defined as pH ≤ 11)." The source text indicates that mild alkaline enzymatic cleaners are now included in the acceptable range.
The affected documentation was distributed to Florida and South Carolina. Users of the EndoWrist Stapler 45 System should verify their documentation against the recall notice and update their cleaning procedures to reflect the revised pH specifications to ensure proper device maintenance.
The recalled product
- Product
- EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System and EndoWrist Stapler 45 Reloads are intended to be used with the da Vinci Si Surgical System (Model IS3000) for resection, transection and/or creation of anastomoses in General, Gyn
- Manufacturer
- Intuitive Surgical, Inc.
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model number 410298-05 and 410298-06
Distribution
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