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

Model Number 410322

Device Problem Calibration Problem (2890)

Patient Problem No Information (3190)

Event Date 03/31/2017

Event Type  malfunction  

Event Description

The davinci vessel sealer would not self-calibrate during davinci hysterectomy.

• Brand Name: ENDOWRIST
• Type of Device: SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd.; sunnyvale CA 94086
• MDR Report Key: 6629816
• MDR Text Key: 77218117
• Report Number: 6629816
• Device Sequence Number: 1
• Product Code: NAY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/30/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2019
• Device Model Number: 410322
• Device Lot Number: M10170104
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: Yes

Type of Device Usage