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

Model Number	495NCSC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaints describe that there were issues with the light cable 495ncsc, 495nd and 495ne.As an example it was reported, that the light cable was placed on the patient by accident which caused a burn.The or team left the light source tl400 at 80% and placed the light cord 495ncsc by accident on the patient.In all complaints harm to the patient, surgeon or third party occurred.In conclusion, the complaints are considered as reportable.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that during a procedure on (b)(6)2021 a patient got burned through one of our light cables.The or team left the light source tl400 at 80% and placed the light cord 495ncsc by accident on the patient.

• Brand Name: FIBER OPTIC LIGHT CABLE, 250 CM, Ø4.8 MM
• Common Device Name: LT. 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
• MDR Report Key: 17210171
• Report Number: 9610617-2023-00137
• Device Sequence Number: 14812778
• Product Code: FCW
• UDI-Device Identifier: 04048551290545
• UDI-Public: 4048551290545
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXCEMPT
• 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
• Report Date (Section B): 06/27/2023

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: 495NCSC
• Device Catalogue Number: 495NCSC
• 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: 07/15/2021
• Initial Report FDA Received Date: 06/27/2023
• 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: Unknown