INTUITIVE SURGICAL INC
DA VINCI S · General Hospital
510(k) Clearances (7)
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Recalls (10)
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Reports of friction within certain instrument arms can interrupt smooth instrument motion. This can be felt by the surgeon as resistance in the movement of the master.In this situation, the instrument can stall momentarily and then suddenly catch-up to the master position if the surgeon pushes through the resistance.
Under-Rated Fuses--The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use of an under-rated fuse will result in failure of the fuse and a loss of power to the vision cart, including the loss of power to any ancillary equipment that m
Under-Rated Fuses -- The Firm may have installed incorrect fuses. The daVinci Surgical System Vision Cart's isolation transformer requires a 10A fuse for 115V operation or a 5A fuse for 230V operation. Operation of this product with the use of an under-rated fuse will result in failure of the fuse and a loss of power to the vision cart, including the loss of power to any ancillary equipment that
Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application)
Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.
Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.
Devices may have a ridge on the side of the cannula, which has the potential to abrade instrument shafts and generate black particulate matter.
Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems.
MAUDE Adverse Events (10)
FDA Classification (66)
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