MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI STAPLER

Model Number 470298

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2018

Event Type  malfunction  

Event Description

Davinci stapler locked during procedure.Removed from field.No harm to pt.(b)(4).

• Brand Name: DAVINCI STAPLER
• Type of Device: DAVINCI STAPLER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; 1266 kifer road; bldg 101; sunnyvale CA 94086 5304
• MDR Report Key: 7693350
• MDR Text Key: 114296012
• Report Number: MW5078422
• 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: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 470298
• Device Lot Number: T101803090015
• 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 Age: 71 YR