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

Model Number 470093

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2017

Event Type  malfunction  

Event Description

Robotic davinci xi prograsp arm gears, the white rotating center gear on the head of the instrument fell out after the instrument was removed from the robot.No harm to patient, and used a new instrument to replace.

• Brand Name: ENDOWRIST PROGRASP
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6371683
• MDR Text Key: 68773827
• Report Number: 6371683
• 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: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 470093
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR