MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE; Light Source, Fiberoptic, Routine

Model Number	495NA
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is on-going.Product has been returned for evaluation but has not been completed.Should relevant additional information/investigation results become available, a supplemental medwatch report will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).
Event or Problem Description
It was reported that an event with the 495na fiber optic cable.According to the information received, while using the light cable on a patient, the scope attached to the light cable overheated injuring the patient.Patient suffered what appeared to be thermal burn 1st degree.Per the facility the scope and light cable were used during the entire surgical procedure, approximately 5 hours.The patient suffered what appeared to be a thermal burn 1st degree.
Additional Manufacturer Narrative
This report is to correct the produict code from fcw to the correct product code of oay.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Per manufacture: the product was not returned.According to the customer, the optic 7230aa (zc 200963352 mdr23-124 972991) with the 495na light cable mentioned here heated up considerably during the 5-hour operation and the patient suffered a 1st degree burn.The mentioned light cable was disposed of by the user and is not available for a more detailed investigation of the incident or will not be returned.For this reason, a more detailed investigation and root cause analysis cannot be performed.A possible cause for the strong heating of the optics and the 495na light cable used in combination here and the resulting burn of the patient may be the use of an off-brand light source, a light output set too high or contamination of the light connection on the optics side.Too little distance to the surrounding tissue can also cause a burn.The event is filed under internal karl storz complaint id (b)(4).
Additional Manufacturer Narrative
It was determined that both the product code and 510(k) number associated with this device were incorrect and have since been updated.Therefore, a correction supplemental was submitted to accurately reflect the current product code and 510(k) information.This event is filed under internal complaint id (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE
• Common Device Name: Light Source, Fiberoptic, Routine
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 17136878
• Report Number: 9610617-2023-00125
• Device Sequence Number: 3390312
• Product Code: FCW
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/16/2026
• 2 Devices were Involved in the Event: 1 2

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: 495NA
• Device Catalogue Number: 495NA
• Device Lot Number: CG
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/23/2023
• 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: 05/16/2023
• Supplement Date Received by Manufacturer: 09/29/2023; 09/29/2023; 09/04/2026
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 09/29/2023; 11/15/2023; 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2003
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 7230AA
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 143 LB