MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. DAVINCI ERBE ELECTROSURGICAL GENERATOR; SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

Model Number 11403258

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Discoloration (2074); Burn, Thermal (2530); Full thickness (Third Degree) Burn (2696)

Event Date 06/18/2020

Event Type  Injury  

Event Description

Robotic surgery done and doctors were suturing skin.Upon assessment of skin, care providers noticed burn marks at 2 port sites.Burns were around each port site (around 1/4 inch deep, blackened, burned skin).Trocars used were davinci 8mm long set and davinci xi extra 8mm long set (metal trocars with insulation).Electrolube used on each davinci attachment, bovie did not signal lack of connection to grounding pad, grounding pad was applied and after procedure grounding pad site was clear and free of any signs of redness.In each of the port sites: monopolar curved scissors, long bipolar graspers were used.Cover/cover for davinci arm had no tears breakdown.Team set aside trocars, davinci arms, cover to be examined.Fda safety report id# (b)(4).

• Brand Name: DAVINCI ERBE ELECTROSURGICAL GENERATOR
• Type of Device: SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
• Manufacturer (Section D): INTUITIVE SURGICAL, INC. ; sunnyvale CA 94086 5304
• MDR Report Key: 10307673
• MDR Text Key: 200074175
• Report Number: MW5095655
• 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: 07/19/2020
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11403258
• Device Catalogue Number: REF470400
• Device Lot Number: VER 10 T11190208 0042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 46 YR