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

Model Number 470179

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2020

Event Type  malfunction  

Event Description

Surgeon was using davinci xi monopolar curved scissors and noticed that there was limited movement.Instrument removed from davinci xi robotic arm and on inspection, noticed that the instrument cable is transected.All pieces accounted for and damaged instrument taken off the sterile field.A new instrument was opened in the sterile field and procedure continued without delay.

• 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: 10641372
• MDR Text Key: 210203469
• Report Number: 10641372
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• 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: N131910140086
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12410 DA