MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST XI ROBOTIC INSTRUMENT MONOPOLAR CURVED SCISSORS; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 470179

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2021

Event Type  malfunction  

Event Description

The monopolar scissor instrument bent so that it was unable to be removed through the trocar.

• Brand Name: ENDOWRIST XI ROBOTIC INSTRUMENT MONOPOLAR CURVED SCISSORS
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 11192971
• MDR Text Key: 227510313
• Report Number: 11192971
• 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: 01/07/2021

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: Health Professional
• Device Model Number: 470179
• Device Lot Number: N112009210556
• 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: 01/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/19/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Weight: 52