MAUDE Adverse Event Report: STIHLER ELECTRONIC GMBH ASTODIA; TRANSILLUMINATOR, BATTERY-POWERE

Model Number	DIA120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Gentherm medical, llc., is representing the manufacturer and is submitting this report on their behalf.
Event or Problem Description
Astodia transilluminator used for peripheral arterial line placement and resulted in 2 burns on infant's arm.
Additional Manufacturer Narrative
Neither visual nor functional testing show any deviation from the specified device behavior.Temperature measuring does not show any unexpected values during an usual application which is expected to last less than 1 minute.Gentherm medical, llc., is representing the manufacturer and is submitting this supplemental report on their behalf.

• Brand Name: ASTODIA
• Common Device Name: TRANSILLUMINATOR, BATTERY-POWERE
• Manufacturer (Section D): STIHLER ELECTRONIC GMBH; gaussstrasse 4; 70771 leinfelden-echterdingen; baden-wurttemberg ; GM
• Manufacturer (Section G): STIHLER ELECTRONIC GMBH; 70771 leinfelden-echterdingen; baden-wurttemberg ; GM
• Manufacturer Contact: moritz freimut ; 70771 leinfelden-echterdingen; baden-wurttemberg ; GM
• MDR Report Key: 24208789
• Report Number: 9617473-2026-00001
• Device Sequence Number: 13167884
• Product Code: HJN
• UDI-Device Identifier: 04260114140214
• UDI-Public: 04260114140214
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DIA120
• Device Catalogue Number: DIA120
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown