Intuitive Surgical recalled 7,819 units of the da Vinci S/Si Mega Needle Driver Instrument sold worldwide to hospitals and healthcare providers. The recall cites broken or frayed grip cables that can impair instrument control. Stop using the device and follow the manufacturer’s recall instructions for replacement or service.
Due to increased complaints for broken/frayed grip cables for reusable instruments.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Intuitive Surgical, Inc. or your healthcare provider for instructions. Notification method: Letter
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The da Vinci S/Si Mega Needle Driver Instrument is part of the EndoWrist family used with robotic surgical systems. It enables tissue manipulation, suturing, and probe delivery during minimally invasive procedures.
The defect involves broken or frayed grip cables that transmit motion from the input discs to the distal tip, potentially compromising control during surgery.
This recall is not described as part of a broader industry pattern in the provided notice.
Hospitals and surgical teams must discontinue use of affected devices and arrange replacements or repairs to avoid intraoperative complications and potential delays.
Serials, batch codes, and model numbers are on the instrument label, packaging, or accompanying documentation. The FDA recall page provides the official listing.
Refunds or replacements are typically processed within 4-8 weeks after approval of the recall remedy.
Keep a copy of the recall notice, records of all communications with the manufacturer, and any replacement instrument details.
Model/Catalog Number: 420194. Quantity recalled: 7,819 units. Distribution: Worldwide, including US states CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MO, MS, NC, NJ, NY, OH, PA, TX, VA, WI; countries listed in recall notice. GTIN: 00886874111611. FDA Medical Device Listing Number: D088920.
No injuries or incidents have been reported.
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