Intuitive Surgical recalled 2,095 units of the da Vinci S, Si EndoWrist Tenaculum Forceps Instrument distributed nationwide in the United States and in multiple countries after reports of frayed or broken pitch cables. The defect can compromise instrument control during surgery. Hospitals and surgeons should stop using the device immediately and follow recall instructions from Intuitive Surgical.
Due to increased in complaints regarding frayed or broken pitch cables on reusable surgical 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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Brand: Intuitive Surgical Product: da Vinci S, Si EndoWrist Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Quantity recalled: 2,095 instruments Distribution: U.S. nationwide in AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, WA; Numerous listed countries Classification: Class II Hazard: Frayed or broken pitch cables that transmit motion from input discs to the distal tip Remedy: Stop using the device immediately. Follow recall instructions. Contact Intuitive Surgical or healthcare provider for instructions Recall site
The recall centers on frayed or broken pitch cables within reusable EndoWrist instruments. This fault affects motion transmission along the instrument, potentially reducing control during procedures and increasing the risk of tissue injury.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Intuitive Surgical or your healthcare provider for instructions. 3. Follow the recall letter and manufacturer guidance for next steps. 4. Monitor for recall updates and return or replace per instructions.
FDA recall page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1700-2026. Manufacturer contact details are provided in the recall notice.
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