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

Model Number	495ND
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/13/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported the patient received an approximately dime-sized burn to the upper forearm when the equipment (a telescope attached to an active 495nd light cable connected to a tl400 light source), was laid on the patient and the light cable became disconnected from the scope.The patient required wound treatment.
Additional Manufacturer Narrative
The customer indicated that the event was due to user error, that there was no problem with the equipment, and that it will not be returned for evaluation.This event is filed under internal complaint id (b)(4).This complaint involves a total of 2 items, complaint numbers: (b)(4) and (b)(4) (for the tl400 light source), of which (b)(4) is probably the cause of the burn.There will be no separate report for (b)(4).
Additional Manufacturer Narrative
Our instructions for use explicitly warn against patient contact in connection with the switched-on light source and resulting tissue trauma, and it is explicitly pointed out to the correct connection with the used combination products.This event is filed under internal complaint id (b)(4).

• Brand Name: LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
• Common Device Name: LIGHT CABLE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 16303702
• Report Number: 1221826-2023-00031
• Device Sequence Number: 7049348
• Product Code: FCW
• UDI-Device Identifier: 04048551168899
• UDI-Public: 4048551168899
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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: 495ND
• Device Catalogue Number: 495ND
• 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: 01/25/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 05/09/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 81 KG