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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE SUREFORM 45 DAVINCI XI STAPLER INSTRUMENT SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. INTUITIVE SUREFORM 45 DAVINCI XI STAPLER INSTRUMENT SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 480445
Device Problem Device Slipped (1584)
Patient Problems Blood Loss (2597); Vascular Dissection (3160)
Event Date 02/21/2020
Event Type  Injury  
Event Description
The patient was in the operating room undergoing a right robotic assisted procedure for a pulmonary nodule. Incision was made in the ninth intercostal space and an assistant port was placed in the 10th intercostal space posterior axillary line. The surgeon was at the robotic console and when he was ready to dissect the lung tissue off of the pulmonary artery from the fissure to the hilum, he slid the straight robotic stapler with green reload onto the tissue and clamped the stapler onto the parenchymal tissue. The surgeon saw the message "ready to fire" and when he fired the stapler slid off the tissue and the knife continued to deploy causing a tear of the parenchymal tissue. Pressure was applied to control the bleeding. Out of concern for friable lymph nodes, blood loss and potential injury to the pulmonary artery, the procedure was converted to an open thoracotomy. The bleeding was controlled and the 2 cm tear was repaired. A chest tube was placed. Estimated blood loss was 250cc. The surgery was completed and the patient required an additional two days in the hospital. The sureform 45 straight stapler malfunctioned on the 5th fire of the stapler.
 
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Brand NameINTUITIVE SUREFORM 45 DAVINCI XI STAPLER INSTRUMENT
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
sunnyvale CA 94086
MDR Report Key9971811
MDR Text Key188389329
Report NumberMW5094174
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model Number480445
Device Catalogue Number480445
Device Lot NumberT90190614
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/16/2020 Patient Sequence Number: 1
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