The Recall Desk

FDA (Devices) recall action 80696

Intuitive Surgical, Inc. recalled 2 products on 2018-09-19

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-09-19
Critical
0
Units
65,338

Why these products were recalled

Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the instrument shaft, and may cause fragments of the extension tube to fall, including potentially into the patient.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-09-19

    Intuitive Surgical Recalls da Vinci EndoWrist Scissors Due to Cracking Risk

    Intuitive Surgical is recalling 42,274 da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors because cracks may form in the extension tube, potentially causing fragments to fall into patients.

    Product
    da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt…
    Category
    Distribution
    49 states
  • HighFDA (Devices)··2018-09-19

    Intuitive Surgical Recalls da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors

    Intuitive Surgical is recalling 23,064 da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors because cracks in the extension tube may cause plastic fragments to fall into patients.

    Product
    da Vinci S/Si EndoWrist 8mm Monopolar Curved Scissors Model No. 420179-16 Product Usage: EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt…
    Category
    Distribution
    49 states