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

Model Number 480440

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Davinci synchroseal cut function not working during surgery.

• Brand Name: SYNCHROSEAL
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer road; sunnyvale CA 94086
• MDR Report Key: 14206733
• MDR Text Key: 290061625
• Report Number: 14206733
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 480440
• Device Catalogue Number: 480440
• 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: 02/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White