MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KENDALL; CABLE, ELECTRODE

Model Number	33134
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported a patient injury occurred around 10:02am on (b)(6) 2026 when using cardinal health material # 33134.It was stated that the lead wire caught fire, and damage happened to patient and equipment.They believe the lot number was k251013b based on supply in the clean utility room.
Additional Manufacturer Narrative
The contact office - manufacturing site address was updated in section g.
Additional Manufacturer Narrative
A device history record review for the reported lot number was conducted.All in-process and final acceptance inspections were performed in accordance with established procedures.Inspection results were within acceptable limits, and no manufacturing or inspection anomalies related to the reported issue were identified.No samples or photos were provided for review, so this complaint could not be confirmed nor a root cause determined.No new actions will be taken.If additional information is received, this complaint will be reopened.This complaint will be tracked and trended to determine if there is a need for further actions.

• Brand Name: KENDALL
• Common Device Name: CABLE, ELECTRODE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 25257350
• Report Number: 1423537-2026-00164
• Device Sequence Number: 5419293
• Product Code: IKD
• UDI-Device Identifier: 10192253063066
• UDI-Public: (01)10192253063066(11)1251013(10)K251013B
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2026

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
• Device Model Number: 33134
• Device Catalogue Number: 33134
• Device Lot Number: K251013B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 05/28/2026; 07/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown