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

Model Number 471309

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/05/2021

Event Type  malfunction  

Event Description

The wire popped off the device.

Event Description

The wire popped off the device.

• 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: 12998941
• MDR Text Key: 282198236
• Report Number: 12998941
• 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,Followup
• Report Date: 11/29/2021,09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 471309
• Device Catalogue Number: 471309
• Device Lot Number: N112101040
• 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: 11/29/2021
• Date Report to Manufacturer: 12/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11680 DA
• Patient Sex: Female