MAUDE Adverse Event Report: INTUITIVE SURGICAL INC. PERMANENT CAUTERY SPATULA DAVINCI; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 420184

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Date 05/03/2021

Event Type  malfunction  

Event Description

Insulation on pivoting portion of the davinci spatula instrument head had blackened during use.When the device was removed it had a charcoal like appearance.Fda safety report id # (b)(4).

• Brand Name: PERMANENT CAUTERY SPATULA DAVINCI
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL INC. ; sunnyvale CA 94086
• MDR Report Key: 11783037
• MDR Text Key: 249494651
• Report Number: MW5101192
• Device Sequence Number: 1
• Product Code: NAY
• 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: 05/03/2021

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 Model Number: 420184
• Device Catalogue Number: 420184
• Device Lot Number: N10190212
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2021
• 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: 63 YR