MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI VESSEL SEALER EXTEND; SYSTEM, SURGICAL, COMPUTED CONTROLLED INSTRUMENT

Model Number DA VINCI XI

Device Problem Device Sensing Problem (2917)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2019

Event Type  malfunction  

Event Description

Malfunctioned device x2.Davinci would not recognize instrument plugged into erbe generator.Fda safety report id # (b)(4).

• Brand Name: DA VINCI VESSEL SEALER EXTEND
• Type of Device: SYSTEM, SURGICAL, COMPUTED CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC.; 950 kifer road; sunnyvale CA 94086
• MDR Report Key: 9676958
• MDR Text Key: 178162875
• Report Number: MW5092802
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/03/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DA VINCI XI
• Device Catalogue Number: 480422
• Device Lot Number: M91190908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• 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