Intuitive Surgical recalled 6,152 da Vinci S, Si Permanent Cautery Hook Instruments distributed to U.S. hospitals and clinics overseas. The defect involves frayed or broken pitch cables. Healthcare facilities should stop using the instruments immediately and follow manufacturer recall instructions. If you operate with these tools, consult your supplier or Intuitive Surgical for next steps.
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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These are EndoWrist reusable endoscopic instruments used with the da Vinci S/Si systems for tissue manipulation during minimally invasive procedures. They transmit motion through pitch cables to control the distal tip.
Frayed or broken pitch cables can compromise instrument control and performance during surgery, creating a risk of unintended instrument movement.
This recall is not described as part of a broader industry pattern in the provided data.
Facilities may need to pause certain procedures and inventory affected devices for replacement or return, potentially affecting surgical schedules and supply chains.
Model 420183 and related material numbers, GTIN 00886874111536, FDA Listing D088920 on the device and packaging.
Refunds or replacements typically take 4-8 weeks after verification of eligibility.
Keep serial numbers, lot codes, purchase records, and correspondence with the manufacturer for the recall process.
Model/Catalog Number: 420183 Lot Code: 420183 GTIN: 00886874111536 FDA Medical Device Listing Number: D088920 Material Numbers: 420183-05, 420183-06, 420183-10, 420183-11, 420183-12, 420183-14, 420183-15, 420183-16 System Numbers: USG294; SH0059; SH0075; SH1378; SH1182; SH1390; SH2144; SG704; USG721 Distribution: United States 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; Countries including Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadelu
No injuries or incidents have been reported.
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