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

Model Number 420183

Device Problems Detachment Of Device Component (1104); Device Operates Differently Than Expected (2913); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2018

Event Type  malfunction  

Event Description

The patient was to undergo a robotic prostatectomy procedure in the operating room.The permanent cautery si was to be used in a robotic procedure, but it malfunctioned.When trying to straighten out the instrument to come out of the trocar, it jammed and would not go straight.Because of that, a small piece of the yellow plastic broke off.Piece of black instrument broke off also.

• Brand Name: ENDOWRIST;DAVINCI SI
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1090 kifer road; sunnyvale CA 94086
• MDR Report Key: 7236900
• MDR Text Key: 98869228
• Report Number: 7236900
• 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: 01/25/2018,01/29/2018

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: Physician
• Device Model Number: 420183
• Device Lot Number: M10100123 335
• Other Device ID Number: VERSION VER-04; REPOSABLE DEV
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/25/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/25/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2018
• 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: 63 YR