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

Model Number TL300

Device Problem Excessive Heating (4030)

Patient Problem Burn(s) (1757)

Event Type  Injury  

Event Description

It was reported that the cold light source is causing burns to operators and at least one patient.It was observed that the cold light burns surgical fields as well as surgical dressings, affecting both staff and patients.Another consequence is that it de-sterilizes the burned area.In addition, it was reported that the fiber burned the right index finger of the medical intern.As the cold light source itself has no contact to patients and staff, the involved articles were requested and in addition more details about the number of affected persons were requested.No further detailed information was provided.

Manufacturer Narrative

The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).

Manufacturer Narrative

New information received: the customer stated that he no longer wants to return the device.He affirms that the device works, and the problem was the cables which were too short.According to the new information there is no malfunction of the device and no causality between the device and the burns.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: COLD LIGHT FOUNTAIN POWER LED 300
• Type of Device: COLD LIGHT FOUNTAIN POWER
• 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
• MDR Report Key: 18731540
• MDR Text Key: 335712550
• Report Number: 9610617-2024-00042
• Device Sequence Number: 1
• Product Code: NTN
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TL300
• Device Catalogue Number: TL300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other