MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COLD LIGHT FOUNTAIN POWER LED 300

Model Number	TL300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the information received, the user temporarily placed the guide beam and lens on the patient during the operation.After the operation, it was found that the patient was slightly scalded on the skin where it had been placed.After the scalding observation for a period of time, no other abnormalities were found, and no additional intervention was done.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not returned at the time of mdr submission.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COLD LIGHT FOUNTAIN POWER LED 300
• Common Device Name: COLD LIGHT FOUNTAIN POWER LED 300
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 21537905
• Report Number: 2020550-2025-00369
• Device Sequence Number: 12696542
• Product Code: NTN
• UDI-Device Identifier: 04048551378830
• UDI-Public: 04048551378830
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2025
• Report Date (Section F): 03/06/2025

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?: Yes
• Device Model Number: TL300
• Device Catalogue Number: TL300
• Device Lot Number: XM16435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/04/2025
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown