Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3024-2018 — 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 and sharp dissection, a

U.S. FDA — Device Enforcement · United States · 2018-08-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3024-2018
Date of alert
2018-08-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Intuitive Surgical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00886874111505
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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