MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LIGHT CABLE 4.8MM X 300MM; LIGHT CABLE ASSEMBLY

Model Number	495NE
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was event with a 495ne 4.8mm x 300 light cable.According to the information received the surgeon was doing a laparoscopic procedure and the scope was still partly in the trocar/cannula, however the surgeon laid the scope on the patient's abdomen to get a better angle of view to the target area.Either the shaft of the scope or the light cable junction to the scope's light post then caused a patient burn.
Additional Manufacturer Narrative
Manufacturing site evaluation: the instrument evidence of use: distal end that connects to xenon300 has gouges and discoloration around the fibers.No visible damage to the light fibers.The event is filed under internal karl storz complaint id (b)(4).The ifu ifu im-000003 ifu v17.0 (11-2019) warns never place the end of a fiber optic cable or telescope connected to a light cable on or under a surgical drape while the light source is activated.The intensity of the light may cause burns to the patient and/or the surgical drape.
Additional Manufacturer Narrative
Manufacturing site evaluation: the optic was attached to the patient with the mounted 495ne light cable mentioned in this message, contrary to the warnings in point 2 of the instructions for use resulting in burns.The burns on the patient were caused by the user and not by a manufacturing defect of the optics.The product was found to be specifications.The ifu warns " do not rest the endoscope or the light cable on the patient or where they are in direct contact with surgical accessories." the event is filed under internal karl storz complaint id (b)(4).

• Brand Name: LIGHT CABLE 4.8MM X 300MM
• Common Device Name: LIGHT CABLE ASSEMBLY
• 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: 16742880
• Report Number: 9610617-2023-00075
• Device Sequence Number: 6379309
• Product Code: FCW
• UDI-Device Identifier: 04048551168905
• UDI-Public: 4048551168905
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/14/2023

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: 495NE
• Device Catalogue Number: 495NE
• Device Lot Number: YS04
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2017
• 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
• Patient Weight: 122 KG