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

Model Number 410322

Device Problem Mechanical Jam (2983)

Patient Problem Insufficient Information (4580)

Event Date 08/28/2020

Event Type  malfunction  

Event Description

The jaw of the intuitive surgical endowrist vessel sealer were locked in open position.

• Brand Name: ENDOWRIST;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: 10566233
• MDR Text Key: 207914875
• Report Number: 10566233
• 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: 09/16/2020

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
• Device Model Number: 410322
• Device Lot Number: M11190701
• 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: 09/16/2020
• Date Report to Manufacturer: 09/22/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15695 DA