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 Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2018

Event Type  malfunction  

Event Description

While using the vessel sealer during a robotic cystectomy, blade on vessel sealer stayed exposed and did not retract while not in use.

• 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: 7776539
• MDR Text Key: 116888890
• Report Number: 7776539
• Device Sequence Number: 1
• Product Code: NAY
• UDI-Device Identifier: 00886874111116
• UDI-Public: (01)00886874111116
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/01/2018

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: No Information
• Device Model Number: 410322
• Device Lot Number: M11180322
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2018
• Type of Device Usage: N
• Patient Sequence Number: 1