MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST STAPLER 45; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 470298-11

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2019

Event Type  malfunction  

Event Description

During resection of colon robotic the 45 mm intuitive robotic stapler began to malfunction.Stapler was moving uncontrollably in all directions.Operating room tech able to grab the arm and make it stop.Arm with trocar and stapler in place removed.Another stapler applied and procedure finished with no injury or adverse outcome.Stapler sent out to intuitive for evaluation.

• Brand Name: ENDOWRIST STAPLER 45
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1090 kifer road; sunnyvale CA SUNNY VALE
• MDR Report Key: 8353316
• MDR Text Key: 136602635
• Report Number: 8353316
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2019,02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 470298-11
• Device Lot Number: T10180109
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2019
• Date Report to Manufacturer: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA