MAUDE Adverse Event Report: KARL STORZ ENDOVISION FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM

Model Number	495NA
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Customer will not return the device to us, and therefore will not be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal case # (b)(4).
Event or Problem Description
It was reported that during a cystoscopy on (b)(6) 2024, the patient was burned by the light cord.The light source was on but not attached to the scope.The light cord was draped across the patient and they sustained a burn.
Additional Manufacturer Narrative
Additional information: received a copy of the medwatch (number (b)(4)) which customer filed from their end.I updated section a with addtional patient information.Customer will not return the device to us, and therefore will not be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal case number (b)(4).
Additional Manufacturer Narrative
Additional information is provided per fda request in section h10.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: lot code was not provided therefore manufacturing history cannot be retrieved.Evaluation cannot be performed due to light cable not being returned.Possible root cause for failure may be attributed to the defective connection point between the light cable and the scope's adapter.This nonconformity has been identified and being addressed internally.This event is filed under internal case number (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM
• Common Device Name: FIBER OPTIC 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 90245 ; 4242188247
• MDR Report Key: 20562204
• Report Number: 1221826-2024-00413
• Device Sequence Number: 8979688
• Product Code: FCW
• UDI-Device Identifier: 04048551168868
• UDI-Public: 04048551168868
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/24/2025

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: 495NA
• Device Catalogue Number: 495NA
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 12/16/2024; 01/13/2025; 03/21/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 12/16/2024; 01/13/2025; 03/24/2025
• 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: Female
• Patient Race: White