MAUDE Adverse Event Report: NOVOCURE GmbH Optune Gio

Model Number	TFH9100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	07/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A 65-year-old female with new diagnosed glioblastoma (gbm) started optune gio therapy on (b)(6)2023.On (b)(6)2026, the patient informed novocure that he had been experiencing headaches and occasional sharp head pains since (b)(6)2026, while wearing the arrays.The patient used oxycodone/acetaminophen for the headaches.Multiple attempts were made to contact the prescribing physician; however, no reply was received.
Additional Manufacturer Narrative
Novocure medical opinion is that the contribution of optune gio therapy to the headache cannot be ruled out.Headache is an expected event with optune gio device use (ef-11 16% and 28% ef-14 optune arm).Headache is also an expected symptom of disease in gbm.Note: udi number for the device tfh203786 is (b)(4) ; manufacture date: november 27, 2016.

• Brand Name: Optune Gio
• Common Device Name: Optune Gio
• Manufacturer (Section D): NOVOCURE GmbH
• Manufacturer Contact: sharon perez ; 180 hanover street; portsmouth, NH ; +1(207)752-7602
• MDR Report Key: 50070960
• Report Number: 3010457505-2026-00819
• Device Sequence Number: 10078601
• Product Code: NZK
• UDI-Device Identifier: 07290107982207
• UDI-Public: (01)07290107982207(11)160530
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P100034/S033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/29/2026

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: TFH9100
• Device Catalogue Number: TFH9100US
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 07/04/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/30/2016
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female