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

1 Patient was 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: Health Professional
• Device Expiration Date: 11/30/2018
• Device Lot Number: M10161101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR