MAUDE Adverse Event Report: KARL STORZ ENDOVISION LIGHT CABLE ASSEMBLY, 4.8 MM X 3000MM

Model Number	495NE
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Excessive Heating (4030)
Health Effect - Clinical Code	Bowel Burn (1756)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that during a routine post-operative physician visit the day after a tur procedure, the patient was found to have sustained a burn measuring approximately 1x2 cm.The burn was superficial overall, with an impression of a deeper burn at its canter (2 - 3 degree ).No peripheral redness or significant swelling was noted.The patient was discharged as planned without any delay, with instructions for local wound care.On follow-up two days later, the wound was observed to be healing and closing appropriately.The assumption is that the burn occurred because, following the surgery, the light cable was inadvertently left active and came into contact with either the patient or with the drapes covering the patient.
Additional Manufacturer Narrative
Additional information: a root cause analysis of the light cable cannot be performed because the light cable has not been returned to us despite several written requests for a more detailed root cause analysis.With regard to the customer description, we expressly point out in the instructions for use ifu fiber optic light cable, that the light cable must not be placed near flammable materials or near the patient and must not be directed at the patient.According to the customer's description, it is possible that the light cable (light outlet) mentioned above encountered the patient/covering sheet contrary to the safety instructions mentioned above, resulting in the described burns to the patient.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 3000MM
• Common Device Name: LIGHT CABLE ASSEMBLY, 4.8 MM X 3000MM
• 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
• MDR Report Key: 22337498
• Report Number: 1221826-2025-01095
• Device Sequence Number: 15693991
• Product Code: FCW
• UDI-Device Identifier: 04048551168905
• UDI-Public: 04048551168905
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 10/21/2025

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: 495NE
• Device Catalogue Number: 495NE
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 10/21/2025
• 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: Required Intervention
• Patient Sex: Unknown