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

Device Problem Crack (1135)

Patient Problem No Information (3190)

Event Date 01/11/2018

Event Type  malfunction  

Event Description

During inspection of an xi robotic monopolar curved scissor, the technician found a crack in the plastic collar that surrounds the distal end of the instrument.This crack was discovered before the start of the surgical case.The device was removed and flagged for repair.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer road; sunnyvale CA 97086
• MDR Report Key: 7320418
• MDR Text Key: 101769865
• Report Number: 7320418
• 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: 02/20/2018,02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/20/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1