MAUDE Adverse Event Report: KARL STORZ ENDOVISION LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT; LT. CABLE

Model Number	495ND
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 previous reportability decision for this event was reversed based on a retrospective review.Cut and light leak on cable 780 mm from taper tip 2900 mw output.The complaints describe that there were issues with the light cable 495ncsc, 495nd and 495ne.Further it was reported that the light cable 495nd burned the hand of the doctor when he touched the cord after it was plugged in.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: LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
• Common Device Name: LT. CABLE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton, ma 01507 ; GM 01507
• MDR Report Key: 17210177
• Report Number: 2020550-2023-00138
• Device Sequence Number: 14812780
• Product Code: FCW
• UDI-Device Identifier: 04048551168899
• UDI-Public: 4048551168899
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2023
• Report Date (Section F): 06/26/2023

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: 495ND
• Device Catalogue Number: 495ND
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown