MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. INTUITIVE SURGICAL INC.; DA VINCI XI ENDOWRIST STAPLER 45

Model Number DA VINCI XI

Device Problems Failure to Advance (2524); Device Displays Incorrect Message (2591); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/29/2017

Event Type  Other  

Event Description

Gears making strange sounds during calibration, arm blinking yellow (meaning error) will not allow advancement of instrument into pt.Tested instrument after case completed, with same resulting errors.Multiple attempts were tried with different sterile drapes/adapters without satisfactory functioning.No pt harm.

• Brand Name: INTUITIVE SURGICAL INC.
• Type of Device: DA VINCI XI ENDOWRIST STAPLER 45
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; 950 kifer road; sunnyvale CA 94086
• MDR Report Key: 7104609
• MDR Text Key: 94496015
• Report Number: MW5073889
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DA VINCI XI
• Device Catalogue Number: 470398-11
• Device Lot Number: S10160818-0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1