MAUDE Adverse Event Report: KARL STORZ SE & CO. KG FIBER OPTIC LIGHT CABLE, 250 CM, Ø4.8 MM

Model Number	495NCS
Medical Device Problem Codes	Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The event occurred in germany.It was reported that the surgeon placed the warm light carrier on the patient.The patient suffered burns.Because the patient suffered burns, the case is classified as reportable.Additional patient information is not available.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
As stated by the customer, the laryngoscopy light carrier connected to the light source was placed on the patient by the user, causing the patient to suffer burns.An explicit warning against patient contact in connection with the switched-on light source and resulting tissue traumatization is clearly described in the associated instructions for use.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE, 250 CM, Ø4.8 MM
• Common Device Name: FIBER OPTIC LIGHT CABLE
• 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 90245-5017 ; 4242188738
• MDR Report Key: 16526704
• Report Number: 9610617-2023-00058
• Device Sequence Number: 2620067
• Product Code: FCW
• UDI-Device Identifier: 04048551001141
• UDI-Public: 4048551001141
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 495NCS
• Device Catalogue Number: 495NCS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 05/10/2023
• 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