🔍 RecallPedia

8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344

Class I - Dangerous
🏥 Medical Devices Recalled: December 19, 2024 Intuitive Surgical Other Medical Devices

What Should You Do?

  1. Check if you have this product:
    Model Number: 471344 Part Number: 471344-17 UDI-DI code: 00886874121511 Batch Numbers: K10230302 K10230310 K10230504 K10230511 K10230525 K10230601 K10230608 K10231019 K10231027 K10231102 K10231218 K10240118 K10240229 K10240411 K10240418 K10240502 K10240509 K10240516 K10240606 K10240627 K10240702 K10240711 K11240418 K16240508
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Intuitive Surgical, Inc.
Reason for Recall:
Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

8MM,CURVED BIPOLAR DISSECTOR,IS4000 REF 471344

Product Codes/Lot Numbers:

Model Number: 471344 Part Number: 471344-17 UDI-DI code: 00886874121511 Batch Numbers: K10230302 K10230310 K10230504 K10230511 K10230525 K10230601 K10230608 K10231019 K10231027 K10231102 K10231218 K10240118 K10240229 K10240411 K10240418 K10240502 K10240509 K10240516 K10240606 K10240627 K10240702 K10240711 K11240418 K16240508

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0881-2025

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Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EndoWrist Instruments or da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use. All da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient). Component: NA

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