MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI XI; SYSTEM SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number SK1352

Device Problems Mechanical Jam (2983); Output Problem (3005)

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

Event Date 07/16/2018

Event Type  malfunction  

Event Description

Da vinci xi robot malfunctions during operating room case with codes 319 and 252.An arm failure occurred causing machine to lock up and unable to use the robotic technique any further in the case.An emergency shut down and instruments removed.Inguinal hernia repair had to convert to open surgery.

• Brand Name: DA VINCI XI
• Type of Device: SYSTEM SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.
• MDR Report Key: 7757419
• MDR Text Key: 116591209
• Report Number: MW5078905
• Device Sequence Number: 0
• Product Code: NAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SK1352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2018
• 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
• Patient Age: 43 YR
• Patient Weight: 125