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

Model Number	495ND
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that they were doing an emergency lap surgery.They were using adapter from the rigid scope to the fiber optic cable.Those adapters only have two threads on them and the fibert optic cable came undone and fell on the draping for the case and caught fire.They are asking to have these three items (scope, image1s, and cable) evaluated to make sure there are no heat, smoke, or other damaged through them.No negative impact in state of health reported.Product 2 concomitant device filed under internal complaint id (b)(4).Product 3 concomitant device filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
The device will 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 complaint id (b)(4).Cross reference interal complaint id (b)(4).
Additional Manufacturer Narrative
The reported customer complaint text states that they were using adapter from the rigid scope to the fiber optic cable.Those adapters only have two threads on them and the fibert optic cable came undone and fell on the draping for the case and caught fire.Also, the light cable will not be returning as it is believed to be an issue with the two-threaded adapter.This failure mode was attributed to be the two-threaded adapter, not the light cable.No further investigation as this failure mode is not a design/manufacturing related defect of the light cable.This event is filed under internal complaint id (b)(4).Cross reference interal complaint id (b)(4) cross reference interal complaint id (b)(4).

• Brand Name: LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
• Common Device Name: LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT
• 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 avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 24317458
• Report Number: 1221826-2026-00277
• Device Sequence Number: 5650266
• Product Code: FCW
• UDI-Device Identifier: 04048551168899
• UDI-Public: 04048551168899
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 02/19/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/11/2026
• Supplement Report FDA Received Date: 02/19/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 26046BRA HOPKINS RUBINA 30°, NIR/ICG, Ø 5 MM; TH121 IMAGE1S 4U RUBINA, OPAL1 NIR/ICG
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown