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

Model Number 410322

Device Problem Retraction Problem (1536)

Patient Problem No Information (3190)

Event Date 05/09/2019

Event Type  malfunction  

Event Description

Intuitive surgical, endo wrist one, vessel sealer noted a default error message and would not let the device blade retract.Exchanged for "like" device that worked without issue.Was this device serviced by a third party servicer? no.Fda safety report id # (b)(4).

• Brand Name: VESSEL SEALER
• Type of Device: SYSTEM SURGICAL COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; sunnyvale CA 94086
• MDR Report Key: 8608416
• MDR Text Key: 145267015
• Report Number: MW5086615
• 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: Nurse
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 410322
• Device Catalogue Number: 410322
• Device Lot Number: M11181105
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/13/2019
• 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: 61 YR