MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG ARVEO; SURGICAL MICROSCOPE

Model Number ARVEO

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

Patient Problems Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.

Event Description

Leica microsystems (b)(4) received a complaint from usa stating, that the arveo caused a 2nd degree burn on a patient.The burn occurred on a very thin strip of the scalp parallel to the craniotomy incision site.No additional treatment was needed.The patient was discharged 4 days after surgery and was recovering well.

Manufacturer Narrative

This is a final report.An onsite investigation of the affected device revealed, that the arveo worked according to specification, there was no indication of a malfunction.Lamp 1 was found to be engaged and "brightcare plus" was disabled.Because of this we assume, that the device was used in this setting during the surgical procedure.As such we conclude that the 2nd degree burn was caused by high light intensity.The identified root cause for the observed burn is that the user applied a light intensity which was too high for the low working distance used, while "brightcare plus" was deactivated.The user failed to follow the instructions given in the ifu, namely, to start with a low light intensity.But also, to use less light for shorter working distances than for longer working distances, in particular when "brightcare plus" is deactivated.Based on the review of the complaint and mdr database with no (0) similar or identical complaints the issue is evaluated an isolated event.The warnings in the ifu are considered adequate to advice the user on how to properly adjust the light intensity.During an onsite visit we ensured, that the "brightcare plus" function was set to activated in all user settings on all leica surgical operating microscopes belonging to the hospital.Additionally, the users were informed on how to properly activate and deactivate "brightcare plus".

• Brand Name: ARVEO
• Type of Device: SURGICAL MICROSCOPE
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max-schmidheiny-strasse 201; heerbrugg, sankt gallen 9435 ; SZ 9435
• MDR Report Key: 12369846
• MDR Text Key: 268218211
• Report Number: 3003974370-2021-00015
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARVEO
• Device Catalogue Number: 10448999
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other