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

Model Number 410322

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2016

Event Type  malfunction  

Event Description

While using the vessel sealer on a robotic procedure, it faulted and stated blade exposed, cannot retract.New item used for a few uses and then this item faulted, a 3rd one had to be opened to finish the dissection.Pt was not harmed, approximately 5 minute delay to switch out the instruments.This has happened several times with this piece of equipment.Response by operating room manager: the manufacturer of the robotic vessel sealers is intuitive.The 2 vessel sealers that were not functioning properly are in our inventory specialist's office.We contacted the intuitive rep and they are coming in to look at the sealers.At the time the problem occurred, the intuitive hotline was called to make them aware of the issues.They believe that it is most likely a generator or circuit issue and not an issue with the sealers themselves.Once they come in to look at the sealers and robot itself it will be determined what to do next with the items.The patient was having a robotic cystoprostatectomy intracorporeal neobladder.Procedure.Manufacturer response for endowrist one vessel sealer x2, da vinci (per site reporter): at the time the problem occurred, the intuitive hotline was called to make them aware of the issues.They believe that it is most likely a generator or circuit issue and not an issue with the sealers themselves.Once they come in to look at the sealers and robot itself it will be determined what to do next with the items.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer road; sunnyvale CA 94086
• MDR Report Key: 6218104
• MDR Text Key: 63737248
• Report Number: 6218104
• 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: 12/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 08/01/2018
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/21/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 46 YR