MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. DAVINCI STAPLER 45; STAPLE, IMPLANTABLE

Model Number 470298

Device Problem Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  malfunction  

Event Description

Davinci stapler 45 malfunctioned when surgeon was trying to staple pt's stomach.Instrument pulled out from table, replacement and new stapler worked properly.No harm to pt.(b)(4).

• Brand Name: DAVINCI STAPLER 45
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): INTUITIVE SURGICAL INC.
• MDR Report Key: 7529813
• MDR Text Key: 108920691
• Report Number: MW5077336
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: T11180214
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/18/2018
• 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: 50 YR