MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST ONE VESSEL SEALER DAVINCI SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 410322

Device Problem Failure to Sense (1559)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2020

Event Type  malfunction  

Event Description

Si robot would not recognize the endowrist one vessel sealer. Solid yellow light remained on robot arm following several attempts by staff for it to be recognized. Fda safety report id # (b)(4).

• Brand Name: ENDOWRIST ONE VESSEL SEALER DAVINCI
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• MDR Report Key: 10976388
• MDR Text Key: 220915978
• Report Number: MW5098279
• Device Sequence Number: 1
• Product Code: NAY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2022
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Device Lot Number: M10200121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage