MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE

Model Number	495TIP
Medical Device Problem Codes	Component Incompatible (1108); Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was event with a 495tip fiber optic light cable 330cm,4.8mm.According to the information received, the thick 495tip light cable was attached to a laryngoscope light carrier.Heat was generated at the light carrier and light cable connection as it is not the appropriate light cable for the light carrier.The metal connector must have been touching the patient's nose as the patient had a burn on the nose.
Additional Manufacturer Narrative
Manufacturing site evaluation: the customer will not be returning the product.The sales rep has set up in services with staff to educate on thin versus thick light cables and when to use each.The ifu for 495tip 970000213 v.3 11/2017 states use of appropriate size light cable to be used to minimize the heat energy generated from the light source.Use of the appropriate size light cable will reduce the risk of patient burns.The event is filed under internal karl storz complaint id (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: do to missing information on the part of the customer (batch), no information on the product history can be given.According to the information provided, a light cable not suitable for the combination was used on the optics and an increased temperature was created.According to the data, the light connector came into contact with the patient's nose, which resulted in a burn.The user acted contrary to the stated instructions in the user manual.A more detailed examination of the light cable could not be carried out, as the 495tip light cable was not returned for examination.The ifu for 495tip 970000213 v.3 11/2017 states use of appropriate size light cable to be used to minimize the heat energy generated from the light source.Use of the appropriate size light cable will reduce the risk of patient burns.4.2 of the ifu provides a chart of the possible combinations of the light cable diameter and the endoscope diameter.The ifu warns to check that the product is suitable for the procedure prior to use, the warning in 3.3 hot components states " prevent the distal end, light connections, and adjacent components from coming into contact with tissue and operating room accessories.The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE
• Common Device Name: LIGHT CABLE
• 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 ; 4244188247
• MDR Report Key: 16989038
• Report Number: 9610617-2023-00105
• Device Sequence Number: 12453159
• Product Code: FCW
• UDI-Device Identifier: 04048551168905
• UDI-Public: 4048551168905
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2023

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: 495TIP
• Device Catalogue Number: 495TIP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 04/25/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 09/19/2023
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male