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

Lot Number M10161101

Device Problems Retraction Problem (1536); Physical Resistance/Sticking (4012)

Patient Problem No Information (3190)

Event Date 05/24/2018

Event Type  malfunction  

Event Description

Vessel sealer blade was stuck and would not retract causing a recoverable fault on the robot. Second vessel sealer with different lot number was opened and had the same malfunction. A third vessel sealer with the same lot number as the first was opened and functioned without issue.

• Brand Name: VESSEL SEALER
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 1266 kifer rd; building 101; sunnyvale CA 94086 5304
• MDR Report Key: 7769149
• MDR Text Key: 116798945
• Report Number: MW5078988
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/01/2018
• 2 Devices were Involved in the Event: 1 2

0 Patients were Involved in the Event:

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2018
• Device Lot Number: M10161101
• 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