MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. INTUITIVE DA VINCI CLIP APPLICATOR

Model Number 470230

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  Injury  

Event Description

The clip for the intuitive da vinci clip applicator could not load, several clips failed to adhere.No harm to the pt.

• Brand Name: INTUITIVE DA VINCI CLIP APPLICATOR
• Type of Device: INTUITIVE DA VINCI CLIP APPLICATOR
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; bldg 101; sunnyvale CA 94086 5304
• MDR Report Key: 7137482
• MDR Text Key: 95476143
• Report Number: MW5074142
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2018
• Device Model Number: 470230
• Device Lot Number: 0072
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR