🔍 RecallPedia

Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2.

Class I - Dangerous
🏥 Medical Devices Recalled: October 2, 2013 Intuitive Surgical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Model number 428080-04 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130510 S10130325 S10130314 S10130314 S10130415 S10130426 S10130329 S10130228 S10130418 S10130304 S10130418 S10130325 S10130325 S10130408 S10130408 S10130510 S10130415 S10130304 S10130314 S10130415 S10130418 S10130228 S10130329 S10130329 S10130415 S10130426 S10130426 S10130426 S10130408 S10130325 S10130228 S10130325 S10130426 S10130426 S10130418 S10130325 S10130510 S10130408 S10130415 S10130408 S10130228 S10130304 S10130418 S10130415 S10130426 S10130314 S10130426 S10130418 S10130228 S10130228 S10130304 S10130415 S10130415 S10130418 S10130408 S10130329 S10130314 S10130228 S10130228 S10130314 S10130325 S10130415 S10130426 Batch/Lot # S10130426 S10130418 S10130408 S10130325 S10130415 S10130415 S10130415 S10130418 S10130325 S10130325 S10130329 S10130325 S10130314 S10130329 S10130426 S10130314 S10130408 S10130329 S10130426 S10130426 S10130325 S10130415 S10130426 S10130426 S10130325 S10130325 S10130325 S10130329 S10130329 S10130408 S10130415 S10130408 S10130408 S10130415 S10130415 S10130418 S10130426 S10130415 S10130325 S10130408 S10130418
  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:
A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2.

Product Codes/Lot Numbers:

Model number 428080-04 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130510 S10130325 S10130314 S10130314 S10130415 S10130426 S10130329 S10130228 S10130418 S10130304 S10130418 S10130325 S10130325 S10130408 S10130408 S10130510 S10130415 S10130304 S10130314 S10130415 S10130418 S10130228 S10130329 S10130329 S10130415 S10130426 S10130426 S10130426 S10130408 S10130325 S10130228 S10130325 S10130426 S10130426 S10130418 S10130325 S10130510 S10130408 S10130415 S10130408 S10130228 S10130304 S10130418 S10130415 S10130426 S10130314 S10130426 S10130418 S10130228 S10130228 S10130304 S10130415 S10130415 S10130418 S10130408 S10130329 S10130314 S10130228 S10130228 S10130314 S10130325 S10130415 S10130426 Batch/Lot # S10130426 S10130418 S10130408 S10130325 S10130415 S10130415 S10130415 S10130418 S10130325 S10130325 S10130329 S10130325 S10130314 S10130329 S10130426 S10130314 S10130408 S10130329 S10130426 S10130426 S10130325 S10130415 S10130426 S10130426 S10130325 S10130325 S10130325 S10130329 S10130329 S10130408 S10130415 S10130408 S10130408 S10130415 S10130415 S10130418 S10130426 S10130415 S10130325 S10130408 S10130418

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0110-2014

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