MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. INTUITIVE SURGICAL INC.; DA VINCI XI CADIERE FORCEPS

Model Number DA VINCI XI

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

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

Event Date 01/11/2017

Event Type  Other  

Event Description

Cable came loose, cable crimp failed.No pt harm.

• Brand Name: INTUITIVE SURGICAL INC.
• Type of Device: DA VINCI XI CADIERE FORCEPS
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; 950 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7104611
• MDR Text Key: 94505921
• Report Number: MW5073891
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 11/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 470049-04
• Device Lot Number: N10160720-0040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2017
• 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