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

Model Number 410322

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2016

Event Type  malfunction  

Event Description

During a robotic procedure, the vessel sealer, ref number (b)(4), lot number m11160719, would not cut.The representative was called to troubleshoot, but the disposable instrument continued to not perform.A second vessel sealer was opened.Disposable sterile surgical supply did not work.Another item was opened and used after the rep was called to troubleshoot the instrument.Patient care was not compromised.

• Brand Name: ENDOWRIST ONE
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6431571
• MDR Text Key: 70780698
• Report Number: 6431571
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 45 YR