MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI XI FENESTRATED BIPOLAR FORCEPS; ENDOSCOPIC INSTRUMENTS AND ACCESSORIES

Model Number DA VINCI XI

Device Problems Thermal Decomposition of Device (1071); Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/13/2017

Event Type  Other  

Event Description

Damage to insulation, cautery stopped working, distal end looks burned.No pt harm.

• Brand Name: DA VINCI XI FENESTRATED BIPOLAR FORCEPS
• Type of Device: ENDOSCOPIC INSTRUMENTS AND ACCESSORIES
• Manufacturer (Section D): INTUITIVE SURGICAL INC.; 950 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7104572
• MDR Text Key: 94483431
• Report Number: MW5073885
• 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: 470205-13
• Device Lot Number: N10160811-0004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• 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