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

Model Number 480299

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 03/22/2018

Event Type  malfunction  

Event Description

Endowrist single use instrument suction irrigator for davinci xi robot malfunctioned; unable to remove it from the trocar.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; sunnyvale CA 94086
• MDR Report Key: 7455373
• MDR Text Key: 106383076
• Report Number: 7455373
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 480299
• Device Catalogue Number: 480299
• Device Lot Number: S1070913
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27 YR