MAUDE Adverse Event Report: RONIN SURGICAL CORPORATION; HEADLAMP, OPERATING, BATTERY-OPERATED

Model Number X6

Device Problems Smoking (1585); Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 07/08/2021

Event Type  malfunction  

Event Description

Doctor was wearing a ronin x6 headlight.Doctor looked out to the field above the loupes and the light was pointing at the surgical gown.After a minute the gown started to steam/smoke.The light was then pointed away.No burn hole in the gown.

• Type of Device: HEADLAMP, OPERATING, BATTERY-OPERATED
• Manufacturer (Section D): RONIN SURGICAL CORPORATION; 6420 avenida wilfredo; la jolla CA 92037
• MDR Report Key: 12664630
• MDR Text Key: 277429758
• Report Number: 12664630
• Device Sequence Number: 1
• Product Code: HPP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: X6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1