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

Model Number 471093

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 03/02/2022

Event Type  malfunction  

Event Description

Wire controlling the movement of the device broke, instrument immediately removed from the body.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 13794846
• MDR Text Key: 287332440
• Report Number: 13794846
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 471093
• Device Lot Number: K102109060088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31390 DA
• Patient Sex: Male