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

Model Number	495NA
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "a member of staff burnt themselves on the proximal end of the light guide cable by holding onto the insulated section, causing the proximal end to swing back and touch their arm.This happened around 4 weeks ago but the exact date and guide cable in use is unknown.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Additional information: the device in question (495na, fiber optic light cable, 230 cm, ø3.5 mm) was not provided for investigation.On the basis of the information provided, the following has been found: the device was not sent to the karl storz assessment and repair department for inspection.The error description provided by the customer, "staff burnt arm on light guide cable", could not be confirmed.According to the information available to us, staff burnt arm on light guide cable.Furthermore, the employee took responsibility for the incident.In the corresponding ifu sap-id 300000478368, we expressly refer to the heating at the light exit aperture in sections 3.7, 3.8, and 3.9.This is not a manufacturing/production defect.The optics/light cable were handled in a manner that deviated from the safety regulations.This is an isolated error; no further measures will be taken.The above investigations did not reveal a root cause related to the labelling, the device, or its history, and no non-conformities were identified in the device's manufacturing records.The labelling was found to contain adequate instructions and warnings.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM
• Common Device Name: FIBER OPTIC LIGHT CABLE, 230 CM, Ø3.5 MM
• Manufacturer (Section D): KARL STORZ ENDOVISION INC; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION INC; 91 carpenter hill road; charlton, 01507 ; GM 01507
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 24260327
• Report Number: 1221826-2026-00223
• Device Sequence Number: 9766727
• Product Code: FCW
• UDI-Device Identifier: 04048551168868
• UDI-Public: 04048551168868
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 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: 01/05/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/25/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown