INTUITIVE SURGICAL INC
DA VINCI SP · General Hospital
510(k) Clearances (26)
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
Substantially Equivalent
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Unknown
Substantially Equivalent
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Substantially Equivalent
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Recalls (9)
Access Port System tray may develop cracks potentially resulting in a sterility breach.
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall.
Surgical system may have inadequately welded top and/or bottom belts in the link 2 of the entry guide manipulator assembly/instrument arm joints, that may cause the following, 1) Top Failure: internal tissue injuries, body wall injury or emergent conversion to open surgery, 2) Bottom failure: pinching injury to the user with no harm to the patient.
Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.
Some cameras were found to have residual soil adhered to the tip of the camera after reprocessing which may affect image quality resulting in needing to switch to a second camera or converting to another surgical modality. If residual soil makes contact with the patient, exposure could result in sensitization making future component blood therapy or tissue typing more challenging; additionally if …
The firm become aware of a potentially defective capacitors on circuit boards installed on certain da Vinci Xi, X and SP system Vision Side Carts (VSC) and/or Patient Side Carts (PSC). As a result, you may experience either vision loss or non-recoverable errors 307 or 319, preventing further use of the system.
Intuitive has become aware that the da Vinci SP system may trigger a mechanical vibration of the instrument tips and endoscope due to a software anomaly. This issue has the potential to occur only under the following, extremely rare specific conditions: 1) the user is activating Adjust Mode, AND 2) the instrument Arm is near its vertical position limit, AND 3) the user is applying sustained force…
The instrument drape may tear while draping the Patient Side Cart presenting a breach in the sterile barrier.
The firm became aware of a problem with the surgical system where the cannula mount button may be damaged when the user releases the button abruptly.
UDI Registrations (4)
VISION SYSTEM CART
PATIENT SIDE CART
SURGEON SIDE CONSOLE
Endoscope, 0°
MAUDE Adverse Events (10)
FDA Classification (66)
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