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

Model Number	TL300
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	05/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The light souce model number tl300 was provided; however, of the model numbers of the rigid telescope and light cable used in the case were not provided.According to the information received thus far: the incident occurred as a result of the warming of the rigid telescope (5mm 30 degrees).The hospital does not know which specific light and optics cable they used in the surgery; however, a tl300 light source was confirmed to have been used in the case.Preliminary investigation shows that the use of the equipment was not in accordance with the manufacturer's instructions, as it is forbidden to place the telescope directly on the patient.The customer is aware of the fact that the use was not in compliance to the ifu, however, moh requests that the manufacturer check the light source and provide his report for this event.
Event or Problem Description
As per manufacturer incident report #(b)(4) received from the factory in (b)(6): the reported event happened in (b)(6).Towards the end of a thorax surgery, the surgeon placed the telescope near the patient's face while the light source was on.After a short time, the anesthetist noticed that there was a slight burn in the sheet.This caused a slight burn near the patient's chin.The patient was treated with an appropriate ointment.

• Brand Name: COLD LIGHT FOUNTAIN POWER LED 300
• Common Device Name: LED LIGHT SOURCE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14852572
• Report Number: 9610617-2022-00099
• Device Sequence Number: 4833099
• Product Code: NTN
• UDI-Device Identifier: 04048551378830
• UDI-Public: 04048551378830
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/29/2022

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
• Operator of Device: Health Professional
• Device Model Number: TL300
• Device Catalogue Number: TL300
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown