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

Device Problems Defective Device (2588); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2020

Event Type  malfunction  

Event Description

During a surgical procedure, the monopolar curved scissors of the da vinci si got stuck in the trocar.The doctor removed the instrument arm from the surgical field.The defective instrument arm was replaced with a new arm and the original intended surgical procedure was resumed without any other further incident.

• Brand Name: DAVINCI SI
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 10441837
• MDR Text Key: 204006467
• Report Number: 10441837
• 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: 08/12/2020

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2020
• Date Report to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17885 DA