MAUDE Adverse Event Report: RONIN SURGICAL CORP. RONIN X6; HEADLAMP, OPERATING, BATTERY-OPERATED

Model Number X6

Device Problem Overheating of Device (1437)

Patient Problem Burn, Thermal (2530)

Event Date 11/02/2020

Event Type  malfunction  

Event Description

During a laminectomy procedure, the surgeon noted burning at the surgical incision site while using a portable high intensity led surgical headlamp system.The surgeon discontinued use of headlamp and proceeded with completion of surgery without additional complications.Follow up with patient occurred to note progress of skin healing.No additional interventions required.During discussion with another surgeon it was discover that an additional surgeon noted burning at the incision site on their unrelated procedure.Two headlamp assemblies sent to biomedical engineering department for evaluation and reporting.Biomedical engineering testing of the headlamp assemblies noted significant warming and heating of a target area when measured with an electronic thermistor-based thermometer.Biomedical engineering also was able to burn and singe a non-reflective surface during testing of the lamp system.Biomedical engineering to contact manufacturer for follow up.Manufacturer response for led surgical light headlamp, ronin x6 (per site reporter).Contacted manufacturer and will follow up with reporting and documenting event.Informed manufacturer that headlamps were pulled from service, pending root cause.

Event Description

During a laminectomy procedure, the surgeon noted burning at the surgical incision site while using a portable high intensity led surgical headlamp system.The surgeon discontinued use of headlamp and proceeded with completion of surgery without additional complications.Follow up with patient occurred to note progress of skin healing.No additional interventions required.During discussion with another surgeon it was discover that an additional surgeon noted burning at the incision site on their unrelated procedure.Two headlamp assemblies sent to biomedical engineering department for evaluation and reporting.Biomedical engineering testing of the headlamp assemblies noted significant warming and heating of a target area when measured with an electronic thermistor-based thermometer.Biomedical engineering also was able to burn and singe a non-reflective surface during testing of the lamp system.Biomedical engineering to contact manufacturer for follow up.Manufacturer response for led surgical light headlamp, ronin x6 (per site reporter).Contacted manufacturer and will follow up with reporting and documenting event.Informed manufacturer that headlamps were pulled from service, pending root cause.

• Brand Name: RONIN X6
• Type of Device: HEADLAMP, OPERATING, BATTERY-OPERATED
• Manufacturer (Section D): RONIN SURGICAL CORP.; 6420 avenida wilfredo; la jolla CA 92037
• MDR Report Key: 11116235
• MDR Text Key: 225063150
• Report Number: 11116235
• 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
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21535 DA