MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DA VINCI PERMANENT CAUTERY HOOK; SYSTEM, SURGICAL, COMPUTER, CONTROLLED

Model Number DA VINCI XI

Device Problem Sparking (2595)

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

Event Date 02/28/2020

Event Type  malfunction  

Event Description

The hook appeared to be sparking/cauterizing from the base, not the curve at the hook.Fda safety report id# (b)(4).

• Brand Name: DA VINCI PERMANENT CAUTERY HOOK
• Type of Device: SYSTEM, SURGICAL, COMPUTER, CONTROLLED
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; 950 kifer road; synnyvale CA 94086
• MDR Report Key: 9828882
• MDR Text Key: 183739726
• Report Number: MW5093716
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: DA VINCI XI
• Device Catalogue Number: 470183
• Device Lot Number: N10191202 0085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• 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