MAUDE Adverse Event Report: KARL STORZ SE & CO. KG LIGHT CABLE, 3.5MM X 300CM. LGTH 9.8 FT

Model Number	495ND
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not return to the manufacturing site for investigation.In the event the device returns and relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.Cross reference complaint id (b)(4).This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported during a hysteroscopy with myosure and mirena iud placement procedure, the light source was on a boom in or, camera and cord were lying across the patient on the bed.Once turned on, the end of the cable sparked, and the drape caught fire.The procedure was completed successfully.No harm to the patient or staff.Cross reference complaint id (b)(4).
Additional Manufacturer Narrative
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.Cross reference complaint id (b)(4).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, 3.5MM X 300CM. LGTH 9.8 FT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 21253213
• Report Number: 9610617-2025-00067
• Device Sequence Number: 8056367
• Product Code: FCW
• UDI-Device Identifier: 04048551168899
• UDI-Public: 04048551168899
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: Not provided
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Age: 39 YR
• Patient Sex: Female