MAUDE Adverse Event Report: KARL STORZ SE & CO. KG Cold Light Fountain Power LED 300

Model Number	TL300
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that prior to surgery, the light source turned off automatically immediately after being powered on.The storz system was restarted; however, the issue persisted.Because the issue could not be resolved despite troubleshooting attempts, the surgery was converted to a laparoscopic approach.Patient involvement is unknown.
Additional Manufacturer Narrative
The affected device is still in use at user's facility and will not be returned to manufacturer for evalaution.The investigation will be performed by a designated karl storz employee, investigation results are pending.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
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 25895006
• Report Number: 9610617-2026-01687
• Device Sequence Number: 9967603
• Product Code: NTN
• UDI-Device Identifier: 04048551378830
• UDI-Public: 04048551378830
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TL300
• Device Catalogue Number: TL300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2026
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 07/21/2026
• Supplement Report FDA Received Date: 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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