MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST;DAVINCI SI; SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT

Model Number 410298

Device Problem Entrapment of Device (1212)

Patient Problem Tissue Damage (2104)

Event Date 06/26/2018

Event Type  malfunction  

Event Description

Stapler caught tissue and would not release so tissue was stuck.Emergency tools had to be used to relieve and free stapler from robotic arm.Blade was exposed.We called the 1-800 number and gave the representative all the information.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7747132
• MDR Text Key: 115934885
• Report Number: 7747132
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 410298
• Device Lot Number: S10170605389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 25550 DA