MAUDE Adverse Event Report: INTUITIVE SURGICAL DAVINCI SI STAPLER 45; ROBOTIC STAPLER

Model Number 410298

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 11/27/2017

Event Type  malfunction  

Event Description

Intuitive surgical da vinci si stapler 45 failed to initialize following 2 attempts.

• Brand Name: DAVINCI SI STAPLER 45
• Type of Device: ROBOTIC STAPLER
• Manufacturer (Section D): INTUITIVE SURGICAL; sunnyvale CA 94086
• MDR Report Key: 7071532
• MDR Text Key: 93474243
• Report Number: MW5073654
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410298
• Device Catalogue Number: 410298
• Device Lot Number: S10170630 551
• 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: 24 YR