MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DA VINCI SI/S LARGE SUTRUECUT NEEDLE DRIVER

Model Number DA VINCI SI

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2016

Event Type  No Answer Provided  

Event Description

Broken/frayed cable at distal end of instrument.No patient harm.

• Brand Name: DA VINCI SI/S LARGE SUTRUECUT NEEDLE DRIVER
• Type of Device: NEEDLE DRIVER
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; sunnyvale CA 94086
• MDR Report Key: 7027345
• MDR Text Key: 92093776
• Report Number: MW5073283
• 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
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DA VINCI SI
• Device Catalogue Number: 420296-04
• Device Lot Number: N10150508-002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• 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